BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2963036 · Received January 24, 2013

    Report

    Report Number
    1218950-2013-00263
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Report Date
    December 31, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS CUSTOMER REPAIR CENTER (CRC) EVALUATED DEVICE. THE DEVICE, AS FOUND/RECEIVED PASSED ALL OPERATIONAL PERFORMANCE ASSURANCE TESTING. THE DEVICE AS FOUND/RECEIVED WAS FULLY FUNCTIONAL. THE SHOCK EQUIP MALFUNCTION INOP COULD NOT BE RECREATED. THE CRC FOUND THAT THE DEVICE STATUS LOG CONTAINED ENTRIES OF CHARGE/SHOCK FAILURE - THERAPY PCA (AUTOTEST). THIS STATUS LOG ENTRY IS INDICATIVE OF A CONDITION THAT CAN CAUSE THE SHOCK EQUIP MALFUNCTION INOP. THE THERAPY PCA WAS REPLACED TO RESOLVE THE STATED PROBLEM. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. THIS WAS A MALFUNCTION OF THE THERAPY PCA THAT CAUSED A CHARGE/SHOCK FAILURE IN TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DISPLAYED THE SHOCK EQUIP MALFUNCTION INOP MESSAGE. THERE WAS NO REPORT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34734 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1