BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 3823846 · Received May 2, 2014

    Report

    Report Number
    1218950-2014-02496
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    April 8, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHILIPS HEALTHCARE THAT DURING DIAGNOSIS OF A (B)(6) YEAR OLD FEMALE PATIENT, THE HEARTSTART MRX SHUT DOWN. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265404 BATTERY 14.8V, 6.3 AH LI-ION BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A 12124-0412-P

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR