BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE

    MDR report key: 4546534 · Received February 19, 2015

    Report

    Report Number
    MW5040907
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BATTERY FAILURE DURING USE IN A SURGERY CASE ON THREE DIFFERENT CASES. COMES UP WITH FAILURE ON DISPLAY, BUT BATTERY INDICATES 100% CHARGED. THERE ARE ON MONITORS THAT ARE LESS THAN 8 MONTHS OLD. BATTERY SHOWS DATE CODE OF 04/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120638 GE HEALTHCARE FLEX-3S3P MHX GE HEALTHCARE FLEX-3S3P U80206

    Patients

    Seq Age Sex Outcome Treatment
    1