BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE, AED

    MDR report key: 1542965 · Received November 20, 2009

    Report

    Report Number
    3003521780-2009-00018
    Event Type
    Death
    Date Received
    November 20, 2009
    Date of Event
    October 15, 2009
    Report Date
    October 26, 2009
    Manufacturer
    DEFIBTECH, LLC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT IS BEING EVALUATED, AND THE INVESTIGATION REMAINS OPEN. RESULT: THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WOULD NOT POWER ON DURING A RESCUE ATTEMPT. IT WAS ALSO REPORTED THAT THE PT 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 57 YR Death