BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 1052337 · Received May 22, 2008

    Report

    Report Number
    3003521780-2008-00006
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 25, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    PMA / PMN Number
    K013896
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT AND THE INTERNAL DEVICE USAGE HISTORY WAS REVIEWED. THE DEVICE USAGE HISTORY RECORD INDICATED THAT THE DEVICE DETECTED A FAULT DUE TO A COMPONENT FAILURE DURING A ROUTINE AUTOMATIC SELF-TEST. THE DEVICE HAD INDICATED THAT SERVICE WAS REQUIRED THROUGH AUDIO AND VISUAL ALERTS FOR SEVERAL MONTHS PRIOR TO THE RESCUE ATTEMPT.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE WAS POWERED ON AND REPORTED A SERVICE CODE MESSAGE. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO ANOTHER DEFIBRILLATOR, AND WAS REPORTED TO HAVE SURVIVED.

    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 75 YR Life Threatening