BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE SCOPE G9

    MDR report key: 21634519 · Received March 18, 2025

    Report

    Report Number
    8030229-2025-04828
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    August 19, 2024
    Report Date
    March 18, 2025
    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
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER ORIGINALLY REPORTED ON TICKETS 216816 AND 217004 THAT THEIR G9 MONITORS WERE UPGRADED TO SW VERSION: 01-46 AND ABOUT A WEEK LATER BEGAN HAVING ISSUES WITH THE VITALS FLASHING OFF AND ON. THIS ISSUE HAD BEEN RESOLVED AT THE TIME AND THE LOG FILES WERE REVIEWED, WHICH FOUND THAT EVENTS FOR REDRAWING THE WAVEFORMS FROM THE SOFTWARE SOURCE CODE REQUIRED A SOFTWARE UPDATE TO VERSION: 01-46, IMPLEMENTING A DESIGN CHANGE FOR THE G9 MONITOR. THIS TICKET WAS CREATED TO SUBSEQUENTLY REPORT THAT THE SAME EVENT OCCURRED ON THIS DEVICE AROUND THE SAME TIME AS THE EVENTS IN THE REFERENCED TICKETS ABOVE. HOWEVER, NK WAS NOT MADE AWARE OF THIS UNTIL NOW. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE ISSUE WAS ESCALATED TO NKC WHERE THEY DETERMINED THAT THE ISSUE WAS FROM A SOFTWARE CODE (01-46) THAT THE CUSTOMER HAD RECENTLY UPGRADED TO. TO RESOLVE THE ISSUE NKC IMPLEMENTED A NEW SOFTWARE VERSION CHANGE (01-47) FOR ALL AFFECTED CUSTOMERS TO UPGRADE THEIR SOFTWARE. AN INVESTIGATION WAS CARRIED OUT FOR TICKETS (216816 AND 217004) UNDER IRC:471. NKC INVESTIGATED THE TRIGGER EVENTS FOR REDRAWING THE WAVEFORMS FROM THE SOFTWARE SOURCE CODE. AS A RESULT, NK WAS ABLE TO CONFIRM THE REPORTED ISSUE AND NKC FOUND THE FOLLOWING PROBABLE CAUSES: IF DATA ANALYSIS (HIGH) TASK DOES NOT OPERATE FOR ONE CYCLE, THE NUMBER OF ECG ELECTRODES IN THE SOURCE CODE IS SET TO AN INVALID VALUE ONCE PER SECOND. THEN, THE WAVEFORM IS REDRAWN, DEPENDING ON THE TIMING OF THE DATA ANALYSIS (HIGH) TASK AND THE ARRHYTHMIA ANALYSIS TASK. IN THE INVESTIGATION, NKC INTENTIONALLY SET AN INVALID VALUE FOR THE NUMBER OF ECG ELECTRODES USING VERIFICATION SOFTWARE. THEN, NKC FOUND THE REPORTED EVENT WAS REPRODUCED. BASED ON THE SYSTEM LOG AND THE REPRODUCED EVENTS, NKC DETERMINED THAT IT WAS THE SAME AS THE EVENT THAT OCCURRED AT THE CUSTOMER'S SITE. A NEW IMPLEMENTATION DESIGN CHANGE FOR THE CSM-1900 SOFTWARE VERSION 01-47 WILL BE ROLLED OUT IN NOVEMBER TIME FRAME. TO RESOLVE THE ISSUE THE CUSTOMER'S SOFTWARE WILL BE UPDATED. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. A COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT COULD NOT PROVIDED: D10 ATTEMPT # 1: 09/04/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 09/10/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: THE CUSTOMER REPLIED THAT THEY WILL NOT BE ABLE TO PROVIDE THE INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER ORIGINALLY REPORTED ON TICKETS 216816 AND 217004 THAT THEIR G9 MONITORS WERE UPGRADED TO SW VERSION: 01-46 AND ABOUT A WEEK LATER BEGAN HAVING ISSUES WITH THE VITALS FLASHING OFF AND ON. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593288 LIFE SCOPE G9 BEDSIDE MONITOR MHX NIHON KOHDEN CORPORATION CU-192R NA 04931921112168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown