BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2945906 · Received January 7, 2013

    Report

    Report Number
    1218950-2013-00065
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 11, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. A FAULTY BATTERY PCA WAS FOUND. THE BATTERY PCA WAS REPLACED TO RESOLVE THE FAILURE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE. THIS WAS A MALFUNCTION OF THE BATTERY PCA THAT CAUSED UNEXPECTED SHUTDOWNS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS SHUTTING DOWN. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8439 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1