BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1184991 · Received October 1, 2008

    Report

    Report Number
    3003521780-2008-00015
    Event Type
    Death
    Date Received
    October 1, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 15, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC HISTORY FILES FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WERE EVALUATED. THE ACTUAL DEVICE WAS NOT RETURNED. ALTHOUGH NO CONCLUSIONS CAN BE MADE BECAUSE THE DEVICE HAS NOT BEEN RETURNED, THE USER REPORTS THAT THEY DO NOT RECALL REMOVING THE RELEASE LINER FROM THE DEFIBRILLATION ELECTRODES DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END CUSTOMER HAD A DIFFICULTY GETTING DEFIBRILLATION ELECTRODES TO STICK TO THE PT DURING A RESCUE ATTEMPT. THE PT WAS TRANSFERRED TO ANOTHER DEFIBRILLATOR WHICH INDICATED THE PT WAS ASYSTOLIC. IT WAS 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 92 YR Death