BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1854487 · Received September 30, 2010

    Report

    Report Number
    1218950-2010-01750
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Report Date
    July 19, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT REMAINS UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN UNEXPECTEDLY AND THEN FAILED TO POWER UP. THERE WAS NO REPORT OF PT INVOLVEMENT.

    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