BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1580999 · Received January 15, 2010

    Report

    Report Number
    3003521780-2010-00001
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 21, 2009
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE ELECTRONIC HISTORY FILED FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE ACTUAL DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE POWERED OFF DURING A RESCUE ATTEMPT. IT WAS REPORTED THAT THE PT WAS TRANSFERRED TO ANOTHER DEFIBRILLATOR, BUT 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 88 YR Death