INTELLIVUE MULTI-MEASUREMENT MODULE X3
Report
- Report Number
- 9610816-2025-000834
- Event Type
- Injury
- Date Received
- September 11, 2025
- Date of Event
- August 17, 2025
- Report Date
- September 30, 2025
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
- Product Code
- MHX
- UDI-DI
- 00884838082588
- PMA / PMN Number
- K171801
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS ONSITE. THE MONITOR, INCLUDING THE SPEAKER, WAS TESTED BY BIOMEDICAL DEPARTMENT AND FOUND TO BE FUNCTIONING AS EXPECTED. LOGS WERE RETRIEVED. THE PATIENT WAS BEING MONITORED STATUS. THE EVENT TOOK PLACE ON AUGUST 17, 2025, WITH THE CUSTOMER ALLEGING NO ALARMS SOUNDS ON THE PULSE AT 18:50 HOURS. THE LOGS WERE REVIEWED BY A PHILIPS ENGINEERING EXPERT. LOW PULSE ALARMS WERE PRESENT AS SHOWN IN THE LOGS AT 18:50:51 THROUGH 18:52:26. ALERT TONES WERE EMITTED DURING THIS TIME. THE ENGINEERING EXPERT ALSO NOTED THAT THERE WERE NO SPEAKER INOPS PRESENT IN THE LOGS INDICATING THE SYSTEM DID NOT DETECT ANY ISSUES WITH THE SPEAKER AT THE EVENT TIME. THE PSE ALSO NOTED THE CONFIGURATIONS FOR THE ALARM VOLUME FROM BEDSIDE MONITOR. THE ALARM TONE AT THE BEDSIDE IS BY DEFAULT SET TO VOLUME 4. THE USER CAN LOWER THE ALARM TO VOLUME 1, BUT A RED ALARM IS 2 VOLUMES HIGHER SO AT THE MINIMUM IS AT VOLUME 3. TECHNICAL INOP¿S WERE NOTED BETWEEN 18:50 AND 18:52: DATE/TIME: (B)(6) 2025 18:50:45, BED: CHILD40, ACTION: USI1C PA NO PULSE GENERATED AT 18:50:44, DEVICE: M134179, ACTION: LOGGED INOP "PRESS LABEL" NO PULSE. DATE/TIME: (B)(6) 2025 18:50:46, BED: CHILD40, ACTION: USI1C PA NO PULSE ENDED, DEVICE: M134179, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:50:46, BED: CHILD40, ACTION: USI1C PA SIGNAL NOISE GENERATED AT 18:50:45, DEVICE: M134179, ACTION: LOGGED INOP "PRESS LABEL" NOISY SIGNAL. DATE/TIME: (B)(6) 2025 18:50:46, ACTION: TECHNICAL ALARM TONE EMITTED, DEVICE: PIC IX: PICIX-ICUPED, ACTION: ALERT SOUND. DATE/TIME: (B)(6) 2025 18:50:46, BED: CHILD40, ACTION: USI1C SECTOR PA NO PULSE GENERATED AT 18:50:44, DEVICE: PIC IX: PICIX-ICUPED, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:50:47, BED: CHILD40, ACTION: USI1C SECTOR PA SIGNAL NOISE GENERATED AT 18:50:45, DEVICE: PIC IX: PICIX-ICUPED, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:50:47, BED: CHILD40, ACTION: USI1C SECTOR: PA NO PULSE ENDED, DEVICE: PIC IX: PICIX-ICUPED, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:50:50, BED: CHILD40, ACTION: USI1C PA SIGNAL NOISE ENDED, DEVICE: M134179, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:50:51, BED: CHILD40, ACTION: USI1C SECTOR: PA SIGNAL NOISE TERMINATED, DEVICE: PIC IX: PICIX-USIPED, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:50:55, BED: CHILD40, ACTION: USI1C SECTOR: PA NO PULSE GENERATED AT 18:50:53, DEVICE: PIC IX: PICIX-USIPED, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:50:55, BED: CHILD40, ACTION: USI1C PA NO PULSE GENERATED AT 18:50:53, DEVICE: M134179, ACTION: LOGGED INOP. DATE/TIME: (B)(6) 2025 18:51:03, ACTION: YELLOW ALARM TONE EMITTED, DEVICE: PIC IX: PICIX-USIPED, ACTION: ALERT SOUND. DATE/TIME: (B)(6) 2025 18:51:07, ACTION: TECHNICAL ALARM TONE EMITTED, DEVICE: PIC IX: PICIX-USIPED, ACTION: ALERT SOUND. DATE/TIME: (B)(6) 2025 18:51:17, ACTION: YELLOW ALARM TONE EMITTED, DEVICE: PIC IX: PICIX-USIPED, ACTION: ALERT SOUND, DATE/TIME: (B)(6) 2025 18:51:20, BED: CHILD40, ACTION: USI1C PA NO PULSE COMPLETED, DEVICE: M134179, ACTION: LOGGED INOP. TWO DIFFERENT INOP¿S WERE NOTED DURING THIS TIME. AS DOCUMENTED ABOVE THERE WAS A ¿PRESS LABEL NO PULSE¿ AND ¿PRESS LABEL NOISY SIGNAL¿. ACCORDING TO THE INTELLIVUE PATIENT MONITOR MX100/X3 RELEASE P WITH SOFTWARE VERSION P.0X.XX INSTRUCTIONS FOR USE (PART NUMBER 453564966151), INOP MESSAGE, INDICATION WHAT TO DO: <PRESS LABEL> NO PULSE THIS INOP CAN ONLY ARISE WHEN A PRESSURE IS SELECTED AS THE PULSE SOURCE. IT OCCURS WHEN THE PULSE RATE BEING MEASURED IS LESS THAN 25 BEATS PER MINUTE OR THE AMPLITUDE IS LESS THAN THREE MMHG. CHECK THE CATHETER AND CONNECTIONS TO THE PATIENT.!! NO PULSE.!!! NO PULSE. PULSE NUMERIC IS REPLACED BY? CORRESPONDING INOP TONE. INOP MESSAGE, INDICATION WHAT TO DO: "PRESS LABEL" NOISY SIGNAL THIS INOP CAN ONLY ARISE WHEN A PRESSURE IS SELECTED AS THE PULSE SOURCE. IT OCCURS WHEN THE PULSE DETECTOR FINDS A PULSE RATE ABOVE 350 BPM. THIS IS USUALLY CAUSED BY MOVEMENT ARTIFACT OR ELECTRICAL INTERFERENCE. PULSE NUMERIC IS REPLACED BY -?- INOP TONE. THE INOP ¿PRESS LABEL NO PULSE¿ CAN BE CONFIGURED AS TECHNICAL YELLOW!! AND RED!!! INOP. ACCORDING TO THE LOGS, THIS INOP WAS CONFIGURED TO NOT ELEVATE AS A YELLOW OR RED ALARM, THIS CAN ALSO BE FOUND IN THE CONFIGURATION OF THE MX750 BEDSIDE MONITOR. THEREFORE, THE MONITOR DID CORRECTLY ANNOUNCE FOR NO PULSE AND NOISY SIGNAL AS TECHNICAL ALARM. THE PHILIPS ENGINEER EXPERT RECOMMENDS THAT THE ¿NO PULSE¿ BE CONFIGURED TO YELLOW OR RED (INSTEAD OF THE CURRENT CYAN SETTING). THE CHANGE WOULD NOTIFY THE USER WITH THE CORRESPONDING YELLOW OR RED ALARMS. FURTHER REVIEW OF THE LOGS SHOWED THAT THERE WAS A RED DESATURATION ALARM ANNOUNCED AT THE CENTRAL AND THE MONITOR PRIOR TO THE INOPS AT 18:45. DATE/TIME: (B)(6) 2025 18:45:36, BED: ENFANT40, ACTION: USI1C DESAT 84 < 85 GENERATED AT 18:45:34, DEVICE: M134179, ACTION: RED ALARM, NOTES: RED ALARM ANNOUNCED AT BEDSIDE. DATE/TIME: (B)(6) 2025 18:45:37, BED: ENFANT40, ACTION: USI1C SECTOR: DESAT 84 < 85 GENERATED AT 18:45:34, DEVICE: PIC IX: PICIX-USIPED, ACTION: RED ALARM, NOTES: RED ALARM ANNOUNCED AT CENTRAL. DATE/TIME: (B)(6) 2025 18:45:37, ACTION: RED ALARM TONE EMITTED, DEVICE: PIC IX: PICIX-USIPED, ACTION: ALERT SOUND, NOTES: RED ALARM SOUND PLAYED AT CENTRAL. AND THIS ALARM WAS SILENCED AT 18:59 FROM THE BEDSIDE MONITOR: DATE/TIME: (B)(6) 2025 18:59:14, BED: CHILD40, ACTION: USI1C DESAT 83 < 85 COMPLETED, DEVICE: M134179, ACTION: RED ALARM. DATE/TIME: (B)(6) 2025 18:59:14, BED: CHILD40, ACTION: USI1C ACKNOWLEDGE, DEVICE: M134179, ACTION: ACKNOWLEDGE. DATE/TIME: (B)(6) 2025 18:59:15, BED: CHILD40, ACTION: USI1C SECTOR: DESAT 83 < 85 COMPLETED, DEVICE: PIC IX: PICIX-USIPED, ACTION: RED ALARM. A NO PULSE INOP WAS ISSUED AT 18:50. HOWEVER, THE RED DESATURATION ALARM AT 18:45 HAD A HIGHER SEVERITY AND THEREFORE THE RED ALARM WAS ANNOUNCED AS THE PRIORITY ALARM. FROM THE INTELLIVUE PATIENT MONITOR MX400/450/500/550/700/800 INSTRUCTIONS FOR USE (IFU) PART NUMBER 453564966911, PAGE 78 AND 79: ALARM LAMP: A LAMP ON THE MONITOR FRONT PANEL, OR ON THE REMOTE ALARM DEVICE, FLASHES OR LIGHTS. THE ALARM LAMP IS DIVIDED INTO TWO SECTIONS. THE RIGHT ONE FLASHES FOR A PATIENT ALARM, EXCEPT FOR SHORT YELLOW ALARMS WHERE THE LAMP WILL LIGHT CONTINUOUSLY FOR APPROXIMATELY SIX SECONDS. THE COLOR IS YELLOW OR RED CORRESPONDING TO THE HIGHEST PRIORITY PATIENT ALARM CURRENTLY PRESENT. THE LEFT ONE LIGHTS CONTINUOUSLY FOR A LIGHT BLUE INOP AND FLASHES FOR YELLOW OR RED INOPS AS FOLLOWS: LAMP COLOR: YELLOW, ON: 1.0 SECONDS, OFF: 1.0 SECONDS. LAMP COLOR: RED, ON: 0.25 SECONDS, OFF: 0.25 SECONDS. IF ONLY PATIENT ALARMS ARE PRESENT, AND NO INOPS, THE PATIENT ALARMS WILL USE BOTH LEFT AND RIGHT SECTIONS TO FLASH (FOR RED AND YELLOW ALARMS) OR LIGHT FOR APPROXIMATELY SIX SECONDS (FOR SHORT YELLOW ALARMS). IF ONLY INOPS ARE PRESENT, AND NO PATIENT ALARMS, RED AND YELLOW INOPS WILL USE BOTH LEFT AND RIGHT SECTIONS TO FLASH BUT LIGHT BLUE INOPS WILL ALWAYS LIGHT CONTINUOUSLY IN THE LEFT SECTION ONLY. AND IN THE ALARM MESSAGE WINDOW THE DIFFERENT ALARMS WILL BE SHOWN, BUT AGAIN HERE THE HIGH PRIORITY ALARMS ARE SHOWN FIRST. PER THE IFU PAGE 89. ALARM MESSAGES WINDOW THE ALARM MESSAGES WINDOW SHOWS ALL THE CURRENTLY ACTIVE ALARMS AND INOPS SORTED BY PRIORITY, BEGINNING AT THE TOP WITH THE MOST RECENT. INOPS ARE SHOWN ON THE LEFT-HAND SIDE AND PATIENT ALARMS ARE SHOWN ON THE RIGHT-HAND SIDE. ANY ACTIVE RED ALARMS ARE SHOWN FIRST, FOLLOWED BY YELLOW ALARMS. ACKNOWLEDGED ALARMS OR INOPS ARE SHOWN WITH THE CHECK MARK SYMBOL. THE ALARM MESSAGES WINDOW POP-UP KEYS APPEAR WHEN THE WINDOW IS OPENED. IF ALARM PAUSE EXTENSION IS DISABLED, THE PAUSE POP-UP KEYS ARE INACTIVE ("GRAYED-OUT"). SELECTING THE REVIEW ALARMS POP-UP KEY OPENS THE REVIEW ALARMS WINDOW. IF YOU DO NOT IMMEDIATELY UNDERSTAND AN INOP OR ALARM MESSAGE, REFER TO ITS HELP TEXT. IN THE ALARM MESSAGES WINDOW, SELECT THE MESSAGE. THIS CALLS UP A HELP WINDOW WITH AN EXPLANATION OF THE MESSAGE AND, WHERE APPROPRIATE, A SUGGESTED SOLUTION FOR THE PROBLEM. IF THE ALARM OR INOP WAS GENERATED IN A DEVICE OTHER THAN THE MONITOR (FOR INSTANCE, IN AN MMS OR FMS), THIS SOURCE IS SPECIFIED AT THE END OF THE HELP TEXT. THE ISSUE WAS NOT CONFIRMED. THE CUSTOMER WILL BE CHANGING THE PULSE ALARM CONFIGURATION TO ADDRESS THE ISSUE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.
A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS ONSITE. THE MONITOR WAS TESTED BY BIOMEDICAL DEPARTMENT AND FOUND TO BE FUNCTIONING AS EXPECTED. LOGS WERE RETRIEVED. THE EVENT TOOK PLACE ON AUGUST 17, 2025 SOMETIME IN THE AFTERNOON BETWEEN 1300 AND 1900 HOURS. THIS WAS LATER CLARIFIED TO INDICATE THE CUSTOMER ALLEGED NO ALARMS SOUNDS ON THE PULSE AT 18:50 HOURS. THE LOGS WERE REVIEWED BY A PHILIPS ENGINEERING EXPERT. LOW PULSE ALARMS WERE PRESENT AS SHOWN IN THE LOGS AT 18:50:51 THROUGH 18:52:26. A DESATURATION ALARM WAS NOTED AT 18:11 AND THIS WAS ACKNOWLEDGED AT THE PIC IX. ADDITIONAL ALARMING AND ACKNOWLEDGEMENTS WERE NOTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
IT WAS REPORTED THE MONITOR DID NOT GENERATE AN AUDIBLE ALARM FOR EPISODES OF ASYSTOLE. THE PATIENT WAS BEING MONITORED STATUS POST CARDIAC SURGERY AND NO AUDIBLE ALARM WAS GENERATED FOR SEVERAL UNNOTICED EPISODES OF ASYSTOLE, WITH THE USER WITNESSING AN 11 SECOND EPISODE OF ASYSTOLE, FOR WHICH NO ALARM WAS GENERATED. ONE OF WHICH WAS 11 SECONDS IN LENGTH. IT WAS ALSO NOTED THE PATIENT HAD AN ATRIOVENTRICULAR BLOCK WITH AN EXTERNAL PACEMAKER IN PLACE. IT WAS INDICATED THE ALARM SOURCE WAS SET TO PULSE WITH THE PULSE SOURCE AS INVASIVE BLOOD PRESSURE. THE CUSTOMER STATED THEY EXPECTED AN ALARM OF 'NO PULSE' TO HAVE OCCURRED ON THE IBP PULSE SOURCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2643918 | INTELLIVUE MULTI-MEASUREMENT MODULE X3 | INTELLIVUE MULTI-MEASUREMENT MODULE X3 | MHX | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | INTELLIVUE X3 | 00884838082588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |