BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2942142 · Received December 28, 2012

    Report

    Report Number
    1218950-2012-04302
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    December 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A FAILURE TO DISCHARGE WHEN RUNNING THE OP CHECK TEST. A PHILIPS FIELD SERVICE ENGINEER 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 AND WAS PLACED BACK INTO USE. THIS WAS A MALFUNCTION OF THE PROCESSOR PCA THAT CAUSED A FAILURE TO DISCHARGE IN TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE WHEN RUNNING THE OP CHECK TEST.

    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