LIFE SCOPE G9
Report
- Report Number
- 8030229-2023-03858
- Event Type
- Malfunction
- Date Received
- October 27, 2023
- Date of Event
- October 3, 2023
- Report Date
- August 13, 2024
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921112168
- PMA / PMN Number
- K213316
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITORING UNIT DID NOT ALARM FOR THE LOW SPO2. THE G9 MONITORING UNIT'S SP02 WAS SET TO ALARM FOR READINGS AT OR BELOW 89, AND THE PATIENT WAS BETWEEN 82-85. AT TIMES, THE ALARM TOOK 2 - 3 MINUTES. NIHON KOHDEN (NK), CLINICAL APPLICATION SPECIALIST (CAS), CONFIRMED THAT THE G9 MONITORING UNIT WAS SET TO DELAY THE SPO2 ALARMS FOR 30 SECONDS TO REDUCE THE NUISANCE ALARMS. BIOMED WOULD LIKE THE LOGS REVIEWED AROUND 10:48 PST WHEN THEY WITNESSED AN EVENT TAKE ALMOST A MINUTE TO ALARM. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE G9 MONITOR: CNS-6801A; MODEL #: PU-681RA; SERIAL #:(B)(6); DEVICE MANUFACTURER DATA: 01/10/2021; UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.
**UDI RELATED DATA QUALITY UPDATES** CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM CSM-1901 TO LIFE SCOPE G9. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CSM-1901 TO CU-192R. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM CSM-1901 TO CU-192RA. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. G4 PREMARKET IDENTIFICATION / PMA/510(K) NUMBER: CORRECTED THE 510(K) # FROM K151080 TO K213316. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE?
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITORING UNIT DID NOT ALARM FOR THE LOW SPO2. THE G9 MONITORING UNIT'S SP02 WAS SET TO ALARM FOR READINGS AT OR BELOW 89, AND THE PATIENT WAS BETWEEN 82-85. AT TIMES, THE ALARM TOOK 2 - 3 MINUTES. NIHON KOHDEN (NK), CLINICAL APPLICATION SPECIALIST (CAS), CONFIRMED THAT THE G9 MONITORING UNIT WAS SET TO DELAY THE SPO2 ALARMS FOR 30 SECONDS TO REDUCE THE NUISANCE ALARMS. BIOMED WOULD LIKE THE LOGS REVIEWED AROUND 10:48 PST WHEN THEY WITNESSED AN EVENT TAKE ALMOST A MINUTE TO ALARM. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. INVESTIGATION SUMMARY: WE WERE UNABLE TO CONFIRM ANY ISSUES WITH THE DEVICES, AS THE BEDSIDE MONITOR WAS FOUND TO BE OPERATING NORMALLY. NKC ANALYZED THE LOGS AND FOUND NO ABNORMAL RECORDS. SINCE ALL INFORMATION CANNOT BE RECORDED IN THE LOG OF CU-192RA OR THE CNS, IT CANNOT BE PROVEN FROM THE LOG INFORMATION, BUT THE POSSIBILITY OF THIS PHENOMENON IS EXPLAINED: THE BEDSIDE MONITOR'S NUMERICAL SAMPLING OCCURS EVERY 1 (ONE) SECOND. THE NUMERICAL DISPLAY ON THE BEDSIDE MONITOR SCREEN IS DISPLAYED EVERY 3 (THREE) SECONDS. THIS BEDSIDE MONITOR'S SPO2 ALARM DELAY TIME WAS REPORTED TO BE 30 (THIRTY) SECONDS. UNDER THE SPECIFICATIONS OF THE BEDSIDE MONITOR DESCRIBED ABOVE, THE SPO2 ALARM DELAY TIME IS SET AS 30 (THIRTY) SECONDS; IF THE VALUE EXCEEDS THE SPO2 LOWER LIMIT OF 89 EVEN FOR 1 SECOND DURING THESE 30 (THIRTY) SECONDS, THE ALARM DELAY TIME COUNT WILL BE RESET. THEREFORE, EVEN IF THE CUSTOMER LOOKS AT THE BEDSIDE MONITOR, THE NUMERICAL VALUE ON THE SCREEN IS DISPLAYED EVERY 3 (THREE) SECONDS. SO, IF THE VALUE EXCEEDS THE SPO2 LOWER LIMIT OF 89 (EIGHTY-NINE) EVERY 1 (ONE) SECOND, THEY WILL NOT BE NOTICED, AND THE ALARM CONDITIONS MAY BE RESET. IN ADDITION, NKC ANALYZED THE INFORMATION (LOGS/FILES) PROVIDED BY THE CUSTOMER. IN THE FILE, THE ONLY TIME SPO2 ON THE VITAL SIGNS LIST WAS BELOW 89 (EIGHTY-NINE) WAS AT 10:49. ASSOCIATED WITH THIS TIME-PERIOD, IT WAS 10:48 SPO2:90 AND 10:50 SPO2:98. BASED ON THESE RECORDS, WE CONCLUDED THAT IT IS UNLIKELY THAT THE SPO2 REMAINED BELOW 89 FOR AT LEAST 2 (TWO) TO 3 (THREE) MINUTES DURING THIS PERIOD. ALSO, IT IS HIGHLY LIKELY THAT THE PATIENT'S SPO2 WAS FLUCTUATING AROUND THE SET LOWER LIMIT. THEREFORE, WE CONCLUDE THAT THE BEDSIDE MONITOR WAS OPERATING NORMALLY. THE REPORTED ISSUE COULD NOT BE CONFIRMED NOR DUPLICATED, AND THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS (ISOLATED INCIDENT). A COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL ANY SIGNIFICANT TRENDS FOR SIMILAR COMPLAINTS. TRENDING WILL CONTINUE TO BE MONITORED. ATTEMPT # 1: 10/04/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION LIST. THE BME REPLIED THAT THEY WOULD NOT SHARE THE PATIENT'S INFORMATION. ATTEMPT # 2: 10/05/2023 EMAILED THE BME FOR THE CONCOMITANT MEDICAL DEVICE. THEY WERE ONLY ABLE TO GIVE THE CNS AND NOT THE BSM-1700. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE G9 MONITOR: BEDSIDE MONITOR: MODEL #: BSM-1700; SERIAL #: NI; DEVICE MANUFACTURER DATA: NI; UNIQUE IDENTIFIER (UDI) #: NI; RETURNED TO NIHON KOHDEN: NA. CNS-6801A. MODEL #: PU-681RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 01/10/2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL MANUFACTURER NARRATIVE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITORING UNIT DID NOT ALARM FOR THE LOW SPO2. THE G9 MONITORING UNIT'S SP02 WAS SET TO ALARM FOR READINGS AT OR BELOW 89, AND THE PATIENT WAS BETWEEN 82-85. AT TIMES, THE ALARM TOOK 2 - 3 MINUTES. NIHON KOHDEN (NK), CLINICAL APPLICATION SPECIALIST (CAS), CONFIRMED THAT THE G9 MONITORING UNIT WAS SET TO DELAY THE SPO2 ALARMS FOR 30 SECONDS TO REDUCE THE NUISANCE ALARMS. BIOMED WOULD LIKE THE LOGS REVIEWED AROUND 10:48 PST WHEN THEY WITNESSED AN EVENT TAKE ALMOST A MINUTE TO ALARM. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. INVESTIGATION SUMMARY: WE WERE UNABLE TO CONFIRM ANY ISSUES WITH THE DEVICES, AS THE BEDSIDE MONITOR WAS FOUND TO BE OPERATING NORMALLY. NKC ANALYZED THE LOGS AND FOUND NO ABNORMAL RECORDS. SINCE ALL INFORMATION CANNOT BE RECORDED IN THE LOG OF CU-192RA OR THE CNS, IT CANNOT BE PROVEN FROM THE LOG INFORMATION, BUT THE POSSIBILITY OF THIS PHENOMENON IS EXPLAINED: THE BEDSIDE MONITOR'S NUMERICAL SAMPLING OCCURS EVERY 1 (ONE) SECOND. THE NUMERICAL DISPLAY ON THE BEDSIDE MONITOR SCREEN IS DISPLAYED EVERY 3 (THREE) SECONDS. THIS BEDSIDE MONITOR'S SPO2 ALARM DELAY TIME WAS REPORTED TO BE 30 (THIRTY) SECONDS. UNDER THE SPECIFICATIONS OF THE BEDSIDE MONITOR DESCRIBED ABOVE, THE SPO2 ALARM DELAY TIME IS SET AS 30 (THIRTY) SECONDS; IF THE VALUE EXCEEDS THE SPO2 LOWER LIMIT OF 89 EVEN FOR 1 SECOND DURING THESE 30 (THIRTY) SECONDS, THE ALARM DELAY TIME COUNT WILL BE RESET. THEREFORE, EVEN IF THE CUSTOMER LOOKS AT THE BEDSIDE MONITOR, THE NUMERICAL VALUE ON THE SCREEN IS DISPLAYED EVERY 3 (THREE) SECONDS. SO, IF THE VALUE EXCEEDS THE SPO2 LOWER LIMIT OF 89 (EIGHTY-NINE) EVERY 1 (ONE) SECOND, THEY WILL NOT BE NOTICED, AND THE ALARM CONDITIONS MAY BE RESET. IN ADDITION, NKC ANALYZED THE INFORMATION (LOGS/FILES) PROVIDED BY THE CUSTOMER. IN THE FILE, THE ONLY TIME SPO2 ON THE VITAL SIGNS LIST WAS BELOW 89 (EIGHTY-NINE) WAS AT 10:49. ASSOCIATED WITH THIS TIME-PERIOD, IT WAS 10:48 SPO2:90 AND 10:50 SPO2:98. BASED ON THESE RECORDS, WE CONCLUDED THAT IT IS UNLIKELY THAT THE SPO2 REMAINED BELOW 89 FOR AT LEAST 2 (TWO) TO 3 (THREE) MINUTES DURING THIS PERIOD. ALSO, IT IS HIGHLY LIKELY THAT THE PATIENT'S SPO2 WAS FLUCTUATING AROUND THE SET LOWER LIMIT. THEREFORE, WE CONCLUDE THAT THE BEDSIDE MONITOR WAS OPERATING NORMALLY. THE REPORTED ISSUE COULD NOT BE CONFIRMED NOR DUPLICATED, AND THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS (ISOLATED INCIDENT). A COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL ANY SIGNIFICANT TRENDS FOR SIMILAR COMPLAINTS. TRENDING WILL CONTINUE TO BE MONITORED. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE G9 MONITOR: BEDSIDE MONITOR: MODEL #: BSM-1700 SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA CNS-6801A MODEL #: PU-681RA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 01/10/2021 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITORING UNIT DID NOT ALARM FOR THE LOW SPO2. NO REPORTS OF PATIENT HARM.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITORING UNIT DID NOT ALARM FOR THE LOW SPO2. NO REPORTS OF PATIENT HARM.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITORING UNIT DID NOT ALARM FOR THE LOW SPO2. NO REPORTS OF PATIENT HARM.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITORING UNIT DID NOT ALARM FOR THE LOW SPO2. NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2138232 | LIFE SCOPE G9 | VITAL SIGNS MONITOR CORE UNIT - G9 (CSM-1901) | MHX | NIHON KOHDEN CORPORATION | CU-192R | NA | 04931921112168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | BSM-1700| BSM-1700| BSM-1700| BSM-1700| CNS| CNS| CNS| CNS |