BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1694219 · Received May 17, 2010

    Report

    Report Number
    3003521780-2010-00008
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT AND SUMMARY : THE ACTUAL DEVICE HAS BEEN RETURNED AND EVALUATED. TESTING TO DATE HAS NOT BEEN ABLE TO REPRODUCE THE REPORTED ERROR, AND THE DEVICE IS FUNCTIONING AS DESIGNED. REVIEW OF THE DEVICE'S ELECTRONIC HISTORY FILE CONFIRMED THE SERVICE MESSAGE AS REPORTED, AND THE INVESTIGATION REMAINS OPEN. A FOLLOW-UP MDR WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE DELIVERED TWO SHOCKS, CANCELLED TWO SHOCKS AND THEN REPORTED A SERVICE MESSAGE AND POWERED OFF. IT WAS REPORTED THAT THE PT WAS NOT RESUSCITATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death