LIFE SCOPE G9
Report
- Report Number
- 8030229-2022-02777
- Event Type
- Malfunction
- Date Received
- April 27, 2022
- Date of Event
- March 27, 2022
- 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
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 (CSM-1901A) WAS ALARMING ADVISORY WHEN IT SHOULD HAVE BEEN ALARMING AS CRITICAL FOR VTACH. THE PATIENT WAS BEING DIRECTLY MONITORED ON THE GZ TELEMETRY TRANSMITTER WHICH WAS THEN MONITORED ON THE G9 USING HIQ VIEW FEATURE. THE BME STATED THEY CANNOT PROVIDE THE SERIAL NUMBER OF THE GZ TELEMETRY TRANSMITTER AS THEY DO NOT KNOW WHICH ONE IT WAS. HOWEVER, THEY STATED THAT ALL THEIR GZS ARE ON SOFTWARE VERSION 02-41. NO PATIENT HARM WAS REPORTED. 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 DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE CSM-1901A, BUT MODEL AND SERIAL NUMBER INFORMATION WAS NOTED AS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE BUT INFORMATION WAS NOT PROVIDED. GZ TELEMETRY TRANSMITTER: MODEL: NI. SN: NI.
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR (CSM-1901A) WAS ALARMING ADVISORY WHEN IT SHOULD HAVE BEEN ALARMING AS CRITICAL FOR VTACH. THE PATIENT WAS BEING DIRECTLY MONITORED ON THE GZ TELEMETRY TRANSMITTER WHICH WAS THEN MONITORED AT THE G9 MONITOR USING THE HIQ VIEW FEATURE. NO HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THIS ISSUE WAS INVESTIGATED BY NKC, INCLUDING EVENT LOGS FOR A PREVIOUS ISSUE REPORTED BY THE CUSTOMER. THE CAUSE OF THE G9 ALARMING AN ADVISORY ALARM WAS DUE TO THE VPC RUN AND V BRADY ALARMS BEING SET TO OFF. IN THE EXPANDED WAVEFORM, 6 CONSECUTIVE VPCS COULD BE CONFIRMED. IN THE EVENT LIST, VRHYTHM AND VPCRUN COULD BE CONFIRMED. ACCORDING TO THE ALARM SETTINGS, VTACHY WAS 5 OR MORE CONSECUTIVE VPCS, AND VPC RUN WAS 4 OR MORE CONSECUTIVE VPCS. THEREFORE, IT SEEMS THAT 6 CONSECUTIVE VPCS WERE DETECTED AS 4 CONSECUTIVE VPCS. THE FIRST VPC MAY NOT HAVE BEEN DETECTED AS A QRS. THE REASON THE SECOND VPC WAS NOT RECOGNIZED AS A VPC IS BECAUSE IT WAS MISTAKENLY RECOGNIZED THAT THE RR INTERVAL OF THE SECOND VPC WAS EXTENDED. SINCE THE SHORTENING OF THE RR INTERVAL WAS RECOGNIZED, THE THIRD VPC WAS JUDGED AS A VPC, AND THE FOURTH, FIFTH, AND SIXTH VPCS WERE ALSO JUDGED AS VPCS. IT WAS CONCLUDED THAT THE CAUSE WAS DERIVED FROM THE PERFORMANCE LIMITATION OF THE ANALYSIS ALGORITHM AND CONFIRMED THE PRODUCT WAS OPERATING NORMALLY ACCORDING TO THE SPECIFICATIONS. THEREFORE, THE CAUSE OF THE ISSUE IS RELATED TO DEVICE LIMITATION AND INCORRECT SETTINGS. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. ADDITIONAL DEVICE INFORMATION: D10: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS BEING USED IN CONJUNCTION WITH THE G9 MONITOR CSM-1901A, BUT THE MODEL AND SERIAL NUMBER INFORMATION IS LISTED AS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE BUT NOT PROVIDED. GZ TELEMETRY TRANSMITTER: MODEL: NI. SN: NI. 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.
**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.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 (CSM-1901A) WAS ALARMING ADVISORY WHEN IT SHOULD HAVE BEEN ALARMING AS CRITICAL FOR VTACH. THE PATIENT WAS BEING DIRECTLY MONITORED ON THE GZ TELEMETRY TRANSMITTER WHICH WAS THEN MONITORED ON THE G9 USING HIQ VIEW FEATURE. THE BME STATED THEY CANNOT PROVIDE THE SERIAL NUMBER OF THE GZ TELEMETRY TRANSMITTER AS THEY DO NOT KNOW WHICH ONE IT WAS. HOWEVER, THEY STATED THAT ALL THEIR GZS ARE ON SOFTWARE VERSION 02-41. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR (CSM-1901A) WAS ALARMING ADVISORY WHEN IT SHOULD HAVE BEEN ALARMING AS CRITICAL FOR VTACH. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR (CSM-1901A) WAS ALARMING ADVISORY WHEN IT SHOULD HAVE BEEN ALARMING AS CRITICAL FOR VTACH. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1861933 | 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 | GZ TELEMETRY TRANSMITTER| GZ TELEMETRY TRANSMITTER| GZ TELEMETRY TRANSMITTER |