BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 3970165 · Received April 29, 2014

    Report

    Report Number
    1218950-2014-02388
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 7, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX BATTERY HAD A PROBLEM, WHICH WAS LATER CLARIFIED AND CONFIRMED BY PHILIPS AUTHORIZED SUPPORT DISTRIBUTOR FSE THAT THE BATTERY WOULD NOT CHARGE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256215 BATTERY 14.8V, 6.3 AH LI-ION BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A 0836-199 REV E

    Patients

    Seq Age Sex Outcome Treatment
    1