BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIHON KOHDEN LIFE SCOPE G7

    MDR report key: 23315404 · Received October 16, 2025

    Report

    Report Number
    MW5177493
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    October 9, 2025
    Report Date
    October 10, 2025
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A NIHON KOHDEN LIFESCOPE G7 PHYSIOLOGIC MONITOR EXPERIENCED AN UNEXPECTED SCREEN LOCK IN THE OPERATING ROOM ON (B)(6) 2025, WHICH CAN IMPAIR THE CLINICIAN'S ABILITY TO MONITOR PATIENT VITAL SIGNS. THIS HAS OCCURRED MULTIPLE TIMES AT OUR HOSPITAL SINCE OPENING IN (B)(6) 2023. IT OCCURRED AGAIN ON (B)(6) 2025 DURING AN URGENT CESAREAN SECTION. THERE ARE AT LEAST 5 OR 6 OTHER TIMES THIS HAS HAPPENED, AND THERE IS NO APPARENT REMEDY OTHER THAN USING A REMOTE CONTROL TO REBOOT THE MONITOR. WE HAVE A DIFFERENT MODEL (LIFESCOPE G9) MONITORS IN ALL OUR OTHER FACILITIES WITH NO REPORTED ISSUES SINCE 2017. NO PATIENT HAS BEEN INJURED OR SUFFERED AN ADVERSE OUTCOME DUE TO THESE GLITCHES, BUT THERE IS A POTENTIAL FOR ADVERSE OUTCOMES IN PARTICULAR SCENARIOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253272 NIHON KOHDEN LIFE SCOPE G7 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX NIHON KOHDEN AMERICA, INC. CU-172R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown