BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2102597 · Received May 20, 2011

    Report

    Report Number
    1218950-2011-01429
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Report Date
    April 22, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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). A PHILIPS FIELD SVC ENGINEER WAS ONSITE FOR SERVICING AND FOUND THIS DEFIBRILLATOR TO FAIL IN TESTING, WHERE IT WAS NOT ABLE TO DISCHARGE. THE PHILIPS REPAIR BENCH EVALUATED THE DEVICE AND NO TROUBLE WAS FOUND. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. PHILIPS IS UNABLE TO CONFIRM THAT A MALFUNCTION OCCURRED. BECAUSE THE PROBLEM COULD NOT BE RECREATED THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A PHILIPS FIELD SVC ENGINEER WAS ONSITE FOR SERVICING AND FOUND THIS DEFIBRILLATOR TO FAIL IN TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1