BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1040431 · Received May 9, 2008

    Report

    Report Number
    3003521780-2008-00005
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    April 10, 2007
    Report Date
    May 9, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    PMA / PMN Number
    K013896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HAS BEEN TESTED SINCE IT WAS RECEIVED FOR EVALUATION. TESTING PERFORMED HAS NOT BEEN ABLE TO DUPLICATE THE ERROR MODE REPORTED BY THE USER.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE WOULD ADVISE SHOCK, CHARGE AND THEN CANCEL THE SHOCK BEFORE THERAPY COULD BE DELIVERED. THE PATIENT WAS TRANSFERRED TO ANOTHER DEFIBRILLATOR, HOWEVER, IT WAS REPORTED THAT THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death