BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 5221070 · Received November 12, 2015

    Report

    Report Number
    1218950-2015-06142
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Report Date
    October 21, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHEN MOVING THE BATTERY THE DEFIBRILLATOR TURNS OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751280 BATTERY 14.8V, 6.3 AH LI-ION BATTERY DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3538A 11297-0020P REV. J

    Patients

    Seq Age Sex Outcome Treatment
    1