BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 1080178 · Received July 17, 2008

    Report

    Report Number
    1218950-2008-00407
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Report Date
    June 23, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THIS FAILURE IS BASED ON INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE DEVICE IS POWERED BY THIS BATTERY, IT CAUSES THE DEVICE TO UNEXPECTEDLY SHUT DOWN WHEN ATTEMPTING TO CHARGE FOR DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATTERY 14.8V, 6.3 AH LI-ION BATTERY DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3538A

    Patients

    Seq Age Sex Outcome Treatment
    1