BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE SCOPE G9

    MDR report key: 21963044 · Received May 5, 2025

    Report

    Report Number
    8030229-2025-04888
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 8, 2025
    Report Date
    July 25, 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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 BEDSIDE MONITOR IS NOT ALARMING, WHEN THE GZ TELEMETER TRANSMITTER (PAIRED VIA HI-Q VIEW MODE) IS GETTING A LOW BATTERY ALARM. BME REPORTED THE ALARM DOES NOT SOUND AT ALL AT THE G9 BEDSIDE MONITOR BUT THE GZ TELEMETER TRANSMITTER AND THE CENTRAL NURSE STATION (CNS) WILL ALARM. NO PATIENT HARM WAS REPORTED. BIOMED SENT IN LOGS FROM THE DEVICE FOR NIHON KOHDEN TO REVIEW. 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: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE G9 MONITOR: BEDSIDE MONITOR (BSM): MODEL #: CU -192R SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 01/08/2021 UNIQUE DEVICE IDENTIFIER (UDI) #: (B)(4) RETURNED TO MANUFACTURER: NA. BEDSIDE MONITOR (BSM): MODEL #: CU-192R SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 01/19/2021 UNIQUE IDENTIFIER (UDI)#: (B)(4) RETURNED TO MANUFACTURER: NA. BEDSIDE MONITOR (BSM): MODEL #: CU-192R SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 01/08/2021 UNIQUE DEVICE IDENTIFIER (UDI)#: (B)(4) RETURNED TO MANUFACTURER: NA. TRANSMITTER: MODEL #: GZ-130P SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 12/02/2021 UNIQUE DEVICE IDENTIFIER (UDI)#: (B)(4) RETURNED TO MANUFACTURER: NA. TRANSMITTER: MODEL #: GZ-130P SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 02/2/2024 UNIQUE DEVICE IDENTIFIER(UDI)#: (B)(4) RETURNED TO MANUFACTURER: NA. TRANSMITTER: MODEL #: GZ-130P SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 12/02/2021 UNIQUE DEVICE IDENTIFIER(UDI)#: (B)(4) RETURNED TO MANUFACTURER: NA.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR WAS NOT ALARMING FOR A LOW BATTERY WHEN THE CONNECTED GZ TRANSMITTER'S BATTERY WAS RUNNING LOW. THE GZ WAS CONNECTED VIA HI-Q VIEW MODE. THE BME STATED THAT THE ALARM DID NOT SOUND AT THE G9, BUT THE GZ AND THE CNS DID ALARM. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE DEVICE LOGS WERE SENT TO NKC FOR INVESTIGATION. ALTHOUGH A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED FROM THE LOGS, IT WAS PRESUMED THE ISSUE MAY HAVE BEEN DUE TO INCORRECT USER WORKFLOW WITH THE HI-Q VIEW FUNCTION. IT APPEARED THAT THE USER WAS CHOOSING THE INCORRECT BED WHEN PAIRING VIA THE HI-Q VIEW MODE. IT SEEMS POSSIBLE THAT THE USER MAY NOT BE AWARE THAT THEY WERE PAIRING HI-Q VIEW WITH TELEMETRY DIFFERENT FROM WHAT THEY INTENDED. THIS MAY CAUSE THE USER TO THINK AN ALARM MAY APPEAR TO BE OCCURRING ON THE GZ AND CNS BUT NOT ON THE G9 (AN ALARM MAY ACTUALLY BE OCCURRING ON A DIFFERENT G9). WE HAVE CONFIRMED THAT THE BATTERY WEEK ALARM OCCURRED DURING A TIME WHEN A DIFFERENT TELEMETRY DEVICE THAN USUAL WAS CONNECTED. BASED ON THE ABOVE, IT IS SPECULATED THAT THE CAUSE OF THE PROBLEM WAS LAUNCHING HI-Q VIEW WITH TELEMETRY DIFFERENT FROM WHAT WAS INTENDED. NK WILL CONTINUE TO MONITOR AND TREND. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE G9 MONITOR: BEDSIDE MONITORS (BSM): MODEL #: CU -192R. SERIAL #S: (B)(6). DEVICE MANUFACTURER DATES: 01/08/2021, 01/19/2021, 01/08/2021. UNIQUE DEVICE IDENTIFIER (UDI) #: (B)(4). RETURNED TO MANUFACTURER: NA. GZ TRANSMITTERS: MODEL #: GZ-130P. SERIAL #S: (B)(6). DEVICE MANUFACTURER DATES: 12/02/2021, 02/2/2024, 12/02/2021. UNIQUE DEVICE IDENTIFIER (UDI)#: (B)(4). RETURNED TO MANUFACTURER: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT D10 CONCOMITANT MEDICAL DEVICE G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 BEDSIDE MONITOR IS NOT ALARMING, WHEN THE GZ TELEMETER TRANSMITTER (PAIRED VIA HI-Q VIEW MODE) IS GETTING A LOW BATTERY ALARM. BME REPORTED THE ALARM DOES NOT SOUND AT ALL AT THE G9 BEDSIDE MONITOR BUT THE GZ TELEMETER TRANSMITTER AND THE CENTRAL NURSE STATION (CNS) WILL ALARM. NO PATIENT HARM WAS REPORTED. BIOMED SENT IN LOGS FROM THE DEVICE FOR NIHON KOHDEN TO REVIEW.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR WAS NOT ALARMING FOR A LOW BATTERY WHEN THE CONNECTED GZ TRANSMITTER'S BATTERY WAS RUNNING LOW. THE GZ WAS CONNECTED VIA HI-Q VIEW MODE. THE BME STATED THAT THE ALARM DID NOT SOUND AT THE G9, BUT THE GZ AND THE CNS DID ALARM. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819344 LIFE SCOPE G9 BEDSIDE MONITOR MHX NIHON KOHDEN CORPORATION CU-192R NA 04931921112168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BEDSIDE MONITORS (BSM)| G9 MONITOR| GZ TRANSMITTER| GZ TRANSMITTERS