BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 5210918 · Received November 9, 2015

    Report

    Report Number
    1218950-2015-06049
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Report Date
    October 15, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART MRX DEFIBRILLATOR BATTERY WAS KEPT ON CHARGE AT THE STATION WHEN THE USER DISCOVERED THAT THE BATTERY WAS NOT ABLE TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742815 BATTERY 14.8V, 6.3 AH LI-ION BATTERY DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3538A

    Patients

    Seq Age Sex Outcome Treatment
    1