INFINITY CENTRAL STATION
Report
- Report Number
- 1220063-2023-00011
- Event Type
- Death
- Date Received
- April 26, 2023
- Date of Event
- March 16, 2023
- Report Date
- April 26, 2023
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC
- Product Code
- MHX
- UDI-DI
- 04049098001878
- PMA / PMN Number
- K093788
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATE: REVIEW OF THE ICS LOGS PROVIDED SHOW THE ALARM PATTERN WAS MANUALLY CHANGED ON (B)(6) 2023 AT 10:49:38AM, PRIOR TO THE DATE/TIME OF THE EVENT (EVENT DATE/TIME 17MAR2023 ~ 5:30AM). (B)(6) 10:49:38 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: IEC FAST CARDIAC. (B)(6) 10:49:38 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: IEC SLOW CARDIAC. THEN AGAIN, MULTIPLE TIMES, AFTER THE REPORTED EVENT: (B)(6) 09:56:01 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: IEC SLOW CARDIAC. (B)(6)10:03:12 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: IEC FAST CARDIAC. (B)(6) 10:03:32 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: IEC FAST CARDIAC. (B)(6) 10:07:33 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: INFINITY. (B)(6) 10:07:33 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: IEC FAST CARDIAC. (B)(6) 10:17:22 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: INFINITY. THE LOGS ALSO SHOW THE FOLLOWING ALARMS WERE PROVIDED STARTING AT ~5:30AM ON (B)(6) 2023: (B)(6) 05:27:20 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D > 110 (B)(6) 05:27:32 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D > 110 (B)(6) 05:27:33 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA D > 110 (B)(6) 05:28:32 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA M > 131 (B)(6) 05:28:34 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA M > 131 (B)(6) 05:32:12 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:32:51 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:32:53 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:33:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:33:29 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:35:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA D < 50 (B)(6) 05:35:34 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 (B)(6) 05:35:36 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA D < 50 (B)(6) 05:37:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:37:33 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6)05:37:35 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:37:37 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:37:47 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:38:04 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:38:08 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:38:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:38:13 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:38:19 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6)05:38:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:38:27 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:38:29 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:38:32 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:38:36 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:38:46 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:39:09 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:39:49 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:40:40 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:40:48 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:40:59 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW (B)(6) 05:41:24 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:41:34 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:41:51 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:41:59 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6)05:43:11 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=SPO2 < 85 (B)(6) 05:43:19 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=0 MSG=SPO2 < 85 (B)(6) 05:43:48 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=SPO2: PAS DE MESURE (B)(6) 05:43:49 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 (B)(6) 05:43:53 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:43:59 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 (B)(6) 05:44:14 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:44:16 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 (B)(6) 05:44:18 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:44:24 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=FC > 130 (B)(6) 05:44:52 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=SPO2: PAS DE MESURE (B)(6) 05:44:53 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 (B)(6) 05:45:11 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:45:17 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 (B)(6) 05:45:19 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:45:42 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:45:52 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:46:06 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:46:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:46:16 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:46:18 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:46:20 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:46:30 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6)05:46:37 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW (B)(6) 05:46:50 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:47:05 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:47:18 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:47:23 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:47:30 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:47:42 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:47:43 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:47:50 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:47:51 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:47:54 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:47:55 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:48:00 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:48:01 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:48:09 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:48:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:48:33 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6)05:48:36 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:48:57 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PRESSION STATIQUE PA (B)(6) 05:49:12 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC < 45 (B)(6) 05:51:22 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE (B)(6) 05:53:44 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:54:02 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:54:06 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:54:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC < 45 (B)(6) 05:54:13 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:54:17 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:54:20 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA (B)(6) 05:54:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE (B)(6)05:54:22 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE (B)(6) 05:54:23 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE (B)(6) 05:54:24 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE (B)(6) 05:54:25 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE (B)(6) 05:55:29 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE (B)(6) 05:55:37 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE. ADDITIONALLY, THE LOGS SHOW THE FOLLOWING USER INTERACTIONS AT THE ICS INCLUDING AUDIO PAUSE AND ALARM SILENCE ENTRIES STARTING (B)(6) AT ~5:30AM, INDICATING THE USER WAS AT THE ICS AND AWARE OF THE ABOVE IDENTIFIED ALARMS PROVIDED. (B)(6) 05:28:33 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 05:32:13 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 05:35:20 CENTRAL: [NOTICE:X0501BF] <LIT4> AUDIO PAUSE BUTTON PRESSED (B)(6) 05:35:20 LAST MESSAGE REPEATED 2 TIMES (B)(6) 05:35:21 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START (B)(6) 05:35:33 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6) 05:35:34 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 05:35:35 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START (B)(6) 05:36:20 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6) 05:36:20 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START (B)(6) 05:37:20 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6) 05:37:21 CENTRAL: [NOTICE:X0501C1] <LIT4> USER SELECTED AUDIO PAUSE STOP (B)(6)05:37:23 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 05:43:18 CENTRAL: [NOTICE:X0501BF] <LIT4> AUDIO PAUSE BUTTON PRESSED (B)(6) 05:43:19 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START (B)(6) 05:43:47 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6)05:43:48 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER (B)(6)05:44:24 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START (B)(6) 05:44:51 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6) 05:44:52 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 05:48:56 CENTRAL: [NOTICE:X0501BF] <LIT4> AUDIO PAUSE BUTTON PRESSED (B)(6) 05:48:57 CENTRAL: [NOTICE:X0501C6] <LIT4> USER SELECTED AUDIO PAUSE START (B)(6) 05:49:11 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6) 05:49:12 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 05:51:44 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START (B)(6) 05:53:44 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6) 05:53:45 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 05:55:49 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START (B)(6) 05:57:49 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP (B)(6) 05:57:50 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 06:01:20 LAST MESSAGE REPEATED 2 TIMES (B)(6) 06:01:32 REPORTMGR: [INFO:X150078] ECG RPT REQ FROM BED <LIT4> ADDED TO REPORT QUEUE (B)(6) 06:01:32 REPORTMGR: [INFO:X150077] ECG REPORT STARTED. (B)(6) 06:01:32 REPORTMGR: [INFO:X150079] ECG REPORT COMPLETED. (B)(6)06:01:34 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 06:09:52 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET (B)(6) 06:28:50 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET. THERE WAS NO DEVICE MALFUNCTION. ***************************************************************************************** INFORMATION SUBMITTED ON 24APR2023: FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE INVOLVED INFINITY CENTRALSTATION (ICS) WAS BEING USED WITH AN INFINITY DELTA PATIENT MONITOR. HOWEVER, THE SPECIFIC DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED. IT WAS CLARIFIED THAT THE PATIENT CONDITION WOULD HAVE WORSENED FROM 5:30 AM ON THE MORNING OF (B)(6) 2023. IT WAS STATED THAT NO MODIFICATIONS WERE MADE TO THE ICS ALARM SETTINGS PRIOR TO THE EVENT, ONLY THE RESTORATION OF THE PARAMETERS BY THE USB KEY. THE ICS CONFIGURATION PRIOR TO THE SOFTWARE UPGRADE WAS "INFINITY" ALARM PATTERN WITH 10% VOLUME. AFTER THE SOFTWARE UPDATE AND CONFIGURATION RESTORATION, THE ALARM PATTERN WAS SET TO "IEC" WITH 10% VOLUME. WE CAN SEE THAT THE ALARMS DURING THE DAY AND NIGHT AT 10% ARE INAUDIBLE. FOLLOWING THIS INCIDENT THE ALARMS WERE SET TO "INFINITY" WITH VOLUME AT 30% AND FUNCTION THUS SINCE. THOUGH THE ICS SOFTWARE DEFAULT SETTINGS FOR ALARM PATTERN IS "IEC FAST", THE DEFAULT VOLUME SETTING IS 50%, NOT 10%. 10% WAS THE ORIGINAL VOLUME SETTING OF THE ICS PRIOR TO THE SOFTWARE UPDATE. AS THE CUSTOMER STATED THAT THE CONFIGURATION WAS RESTORED AFTER THE SOFTWARE UPDATE AND NO MODIFICATIONS WERE MADE, IT CANNOT BE DETERMINED HOW THE SETTINGS WERE MODIFIED. THEREFORE, ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED.
FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE INVOLVED INFINITY CENTRALSTATION (ICS) WAS BEING USED WITH AN INFINITY DELTA PATIENT MONITOR. HOWEVER, THE SPECIFIC DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED. IT WAS CLARIFIED THAT THE PATIENT CONDITION WOULD HAVE WORSENED FROM 5:30AM ON THE MORNING OF (B)(6), 2023. IT WAS STATED THAT NO MODIFICATIONS WERE MADE TO THE ICS ALARM SETTINGS PRIOR TO THE EVENT, ONLY THE RESTORATION OF THE PARAMETERS BY THE USB KEY. THE ICS CONFIGURATION PRIOR TO THE SOFTWARE UPGRADE WAS "INFINITY" ALARM PATTERN WITH 10% VOLUME. AFTER THE SOFTWARE UPDATE AND CONFIGURATION RESTORATION, THE ALARM PATTERN WAS SET TO "IEC" WITH 10% VOLUME. WE CAN SEE THAT THE ALARMS DURING THE DAY AND NIGHT AT 10% ARE INAUDIBLE. FOLLOWING THIS INCIDENT THE ALARMS WERE SET TO "INFINITY" WITH VOLUME AT 30% AND FUNCTION THUS SINCE. REVIEW OF THE LOGS SHOW SOMEONE CHANGED THE ALARM PATTERN ON 16MAR2023 AT 10:49:38AM, PRIOR TO THE DATE/TIME OF THE EVENT (EVENT DATE/TIME 17MAR2023 ~ 5:30AM). (B)(6) 10:49:38 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: IEC FAST CARDIAC. MAR 16 10:49:38 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: IEC SLOW CARDIAC. THE AGAIN, MULTIPLE TIMES, AFTER THE REPORTED EVENT: (B)(6) 09:56:01 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: IEC SLOW CARDIAC. (B)(6) 10:03:12 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: IEC FAST CARDIAC. (B)(6) 10:03:32 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: IEC FAST CARDIAC. (B)(6) 10:07:33 CENTRAL: [NOTICE] SETUP: NEW MEDIUM ALARM TONE PATTERN: INFINITY. (B)(6) 10:07:33 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: IEC FAST CARDIAC. (B)(6) 10:17:22 CENTRAL: [NOTICE] SETUP: NEW LOW ALARM TONE PATTERN: INFINITY. THE LOGS ALSO SHOW THE FOLLOWING ALARMS WERE PROVIDED STARTING AT 5:30AM ON 17MAY2023: MAR 17 05:27:20 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D > 110 MAR 17 05:27:32 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D > 110 MAR 17 05:27:33 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA D > 110 MAR 17 05:28:32 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA M > 131 (B)(6) 05:28:34 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA M > 131 (B)(6) 05:32:12 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:32:51 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:32:53 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:33:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:33:29 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:35:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA D < 50 (B)(6) 05:35:34 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 (B)(6) 05:35:36 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PA D < 50 (B)(6) 05:37:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:37:33 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:37:35 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:37:37 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:37:47 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6) 05:38:04 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:38:08 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 (B)(6)05:38:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 (B)(6) 05:38:13 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:38:19 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:38:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:38:27 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:38:29 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:38:32 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:38:36 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:38:46 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:39:09 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:39:49 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:40:40 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:40:48 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:40:59 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:41:24 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:41:34 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:41:51 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:41:59 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:43:11 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=SPO2 < 85 MAR 17 05:43:19 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=0 MSG=SPO2 < 85 MAR 17 05:43:48 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=SPO2: PAS DE MESURE MAR 17 05:43:49 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 MAR 17 05:43:53 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:43:59 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 MAR 17 05:44:14 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:44:16 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 MAR 17 05:44:18 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:44:24 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=FC > 130 MAR 17 05:44:52 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=SPO2: PAS DE MESURE MAR 17 05:44:53 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 MAR 17 05:45:11 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:45:17 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=ADV FG=BLACK BG=CYAN FLASH=0 MSG=ARTEFACT SPO2 MAR 17 05:45:19 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:45:42 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:45:52 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:46:06 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:46:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:46:16 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:46:18 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:46:20 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:46:30 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:46:37 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:46:50 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:47:05 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:47:18 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:47:23 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:47:30 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:47:42 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:47:43 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:47:50 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:47:51 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:47:54 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:47:55 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:48:00 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:48:01 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:48:09 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:48:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:48:33 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:48:36 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:48:57 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=0 MSG=PRESSION STATIQUE PA MAR 17 05:49:12 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC < 45 MAR 17 05:51:22 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE MAR 17 05:53:44 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:54:02 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:54:06 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:54:10 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC < 45 MAR 17 05:54:13 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=FC > 130 MAR 17 05:54:17 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PA D < 50 MAR 17 05:54:20 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=SER FG=BLACK BG=YELLOW FLASH=1 MSG=PRESSION STATIQUE PA MAR 17 05:54:21 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE MAR 17 05:54:22 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE MAR 17 05:54:23 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE MAR 17 05:54:24 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE MAR 17 05:54:25 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE MAR 17 05:55:29 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE MAR 17 05:55:37 LIT4 DELTA 191.1.1.4 DISPLAY ALARM ON[M] GRADE=LT FG=BLACK BG=RED FLASH=1 MSG=ASYSTOLIE ADDITIONALLY, THE LOGS SHOW THE FOLLOWING USER INTERACTIONS AT THE ICS INCLUDING AUDIO PAUSE AND ALARM SILENCE ENTRIES STARTING AT 17MAR AT 5:30AM, INDICATING THE USER WAS AT THE ICS AND AWARE OF THE ABOVE IDENTIFIED ALARMS PROVIDED. MAR 17 05:28:33 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:32:13 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:35:20 CENTRAL: [NOTICE:X0501BF] <LIT4> AUDIO PAUSE BUTTON PRESSED MAR 17 05:35:20 LAST MESSAGE REPEATED 2 TIMES MAR 17 05:35:21 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START MAR 17 05:35:33 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:35:34 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:35:35 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START MAR 17 05:36:20 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:36:20 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START MAR 17 05:37:20 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:37:21 CENTRAL: [NOTICE:X0501C1] <LIT4> USER SELECTED AUDIO PAUSE STOP MAR 17 05:37:23 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:43:18 CENTRAL: [NOTICE:X0501BF] <LIT4> AUDIO PAUSE BUTTON PRESSED MAR 17 05:43:19 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START MAR 17 05:43:47 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:43:48 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:44:24 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START MAR 17 05:44:51 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:44:52 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:48:56 CENTRAL: [NOTICE:X0501BF] <LIT4> AUDIO PAUSE BUTTON PRESSED MAR 17 05:48:57 CENTRAL: [NOTICE:X0501C6] <LIT4> USER SELECTED AUDIO PAUSE START MAR 17 05:49:11 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:49:12 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:51:44 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START MAR 17 05:53:44 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:53:45 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 05:55:49 CENTRAL: [NOTICE:X0501C8] <LIT4> USER SELECTED ALARM PAUSE START MAR 17 05:57:49 CENTRAL: [NOTICE:X0501C7] <LIT4> USER SELECTED ALARM PAUSE STOP MAR 17 05:57:50 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 06:01:20 LAST MESSAGE REPEATED 2 TIMES MAR 17 06:01:32 REPORTMGR: [INFO:X150078] ECG RPT REQ FROM BED <LIT4> ADDED TO REPORT QUEUE MAR 17 06:01:32 REPORTMGR: [INFO:X150077] ECG REPORT STARTED. MAR 17 06:01:32 REPORTMGR: [INFO:X150079] ECG REPORT COMPLETED. MAR 17 06:01:34 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 06:09:52 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET MAR 17 06:28:50 AUDIOX: [INFO:X02009F] ALARM SILENCE TIMER RESET THERE WAS NO DEVICE MALFUNCTION.
IT WAS REPORTED THAT AN INCIDENT TOOK PLACE BETWEEN (B)(6), THEY NO LONGER HAVE THE EXACT TIME. THE PROBLEM IS THAT THE MIDDLE ALARM (YELLOW) WOULD NOT HAVE BEEN AUDIBLE, RESULTING IN THE DEATH OF THE PATIENT. PRIOR TO THE EVENT, AN UPDATE OF THE ICS CENTRAL WAS PERFORMED (FROM VG2.1.2 TO VG3.0.1). AS A RESULT, THE ALARM SOUND SELECTION WENT FROM INFINITY TO CEI WITH A 10% VOLUME. THE TEAMS WERE NOT USED TO THESE TONES FOR MEDIUM AND LOW ALARMS AND DID NOT REACT. THE ALARM AND VOLUME SETTINGS HAVE SINCE BEEN CORRECTED.
IT WAS REPORTED THAT AN INCIDENT TOOK PLACE BETWEEN (B)(6) 2023, THEY NO LONGER HAVE THE EXACT TIME. THE PROBLEM IS THAT THE MIDDLE ALARM (YELLOW) WOULD NOT HAVE BEEN AUDIBLE, RESULTING IN THE DEATH OF THE PATIENT. PRIOR TO THE EVENT, AN UPDATE OF THE ICS CENTRAL WAS PERFORMED (FROM VG2.1.2 TO VG3.0.1). AS A RESULT, THE ALARM SOUND SELECTION WENT FROM INFINITY TO CEI WITH A 10% VOLUME. THE TEAMS WERE NOT USED TO THESE TONES FOR MEDIUM AND LOW ALARMS AND DID NOT REACT. THE ALARM AND VOLUME SETTINGS HAVE SINCE BEEN CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 668684 | INFINITY CENTRAL STATION | PHYSIOLOGICAL MONITORING SYSTEM | MHX | DRAEGER MEDICAL SYSTEMS, INC | MS26800 | 04049098001878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death | NA.| NA. |