BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2841409 · Received October 23, 2012

    Report

    Report Number
    1218950-2012-03553
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS RESPONSE CENTER (RC) DOCUMENTED THAT THE CUSTOMER REPORTED "FAILED OPS CHECK". THE PHILIPS CUSTOMER REPAIR CENTER (CRC) EVALUATED THE DEVICE AND CLARIFIED AND CONFIRMED THAT THE DEVICE FAILS THE DEFIB TEST SEGMENT OF USER INITIATED OPERATIONAL CHECK (OPCHECK). THE CRC CONFIRMED THE OPCHECK FAILURE CONDITION. THE CRC FOUND THAT THE DEVICE PASSED MANUAL THERAPY TESTING. THE CRC DETERMINED THE CAUSE OF THIS MALFUNCTION TO HAVE BEEN THE HIGH VOLTAGE CAPACITOR IN THE DEFIBRILLATION CIRCUIT. THIS IS A USER INITIATED TESTING ISSUE, THERE WAS NO PT INVOLVEMENT. REPLACEMENT OF THE HIGH VOLTAGE CAPACITOR BY THE RESOLVED THIS MALFUNCTION. THE DEVICE PASSED OPERATIONAL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO THE CUSTOMER. THIS WAS A HIGH VOLTAGE CAPACITOR MALFUNCTION.

    Description of Event or Problem · 1

    THE PHILIPS RESPONSE CENTER (RC) DOCUMENTED THAT THE CUSTOMER REPORTED "FAILED OPS CHECK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1