BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1623526 · Received March 4, 2010

    Report

    Report Number
    3003521780-2010-00003
    Event Type
    Death
    Date Received
    March 4, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 3, 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

    EVALUATION: THE ELECTRONIC HISTORY FILES FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WERE EVALUATED AND INDICATE THAT THE DEVICE IS FUNCTIONING AS DESIGNED. THE ACTUAL DEVICE WAS NOT RETURNED. RESULT: THE ACTUAL DEFIBRILLATION ELECTRODES WERE NOT RECOVERABLE, WITHOUT THE ACTUAL DEFIBRILLATION ELECTRODES, NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESCUE ATTEMPT THE DEVICE ANALYZED, REPORTED THAT NO SHOCK WAS REQUIRED, PAUSED FOR CPR AND REPORTED AN APPLY PADS PROMPT AFTER THE PAUSE FOR CPR. THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE. 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 59 YR Death