BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1790915 · Received August 4, 2010

    Report

    Report Number
    3003521780-2010-00010
    Event Type
    Death
    Date Received
    August 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 8, 2010
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT AND SUMMARY: THE ACTUAL DEVICE HAS BEEN RETURNED AND WAS RECEIVED ON 08/04/2010. THE INVESTIGATION REMAINS OPEN AND A FOLLOW-UP REPORT WILL BE FILED, AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE WOULD NOT POWER ON. A SECOND DEFIBRILLATOR WAS USED, ALTHOUGH NO SHOCKS WERE REQUIRED. IT WAS REPORTED THAT THE PATIENT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death