BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2231053 · Received July 20, 2011

    Report

    Report Number
    1218950-2011-02063
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    June 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED ITS SELF TEST AND WAS FOUND TO BE UNABLE TO DEFIBRILLATE IN TESTING. THE UNIT WAS EVALUATED AT PHILIPS. THE FAILURES REPORTED BY THE CUSTOMER WERE NOT REPRODUCED. THE DEVICE ERROR LOGS WERE EVALUATED. THE EVENT LOGS SUPPORTED THAT THE REPORTED MALFUNCTION OCCURRED. THE PROCESSOR PCA AND RIBBON CABLE WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTS AND WAS RETURNED TO THE CUSTOMER. WE WILL CONSIDER THIS TO BE A MALFUNCTION THAT CAUSED A TEST FAILURE AND THE INABILITY TO DELIVER THERAPY IN TESTING. BECAUSE THE PROBLEM COULD NOT BE RECREATED AND BECAUSE MULTIPLE PARTS WERE REPLACED WE ARE UNABLE TO DETERMINE A SPECIFIC CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED ITS SELF TEST AND WAS FOUND TO BE UNABLE TO DEFIBRILLATE IN TESTING. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1