BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2943281 · Received December 13, 2012

    Report

    Report Number
    1218950-2012-04087
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 20, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP. THERE WAS NO REPORTED PT INVOLVEMENT. A PHILIPS A BENCH TECH EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE PROBLEM WAS TRACED TO A FAULTY PROCESSOR PCA. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE FAILURE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS ADN WAS PLACED BACK INTO THE LOANER POOL. THIS WAS A MALFUNCTION OF THE PROCESSOR PCA THAT CAUSED A FAILURE TO POWER UP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1