BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1991173 · Received February 8, 2011

    Report

    Report Number
    3003521780-2011-00003
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Removal / Correction Number
    Z-0580-2007, Z-0581-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODE: THE ELECTRONIC HISTORY FILE FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE ACTUAL DEVICE WAS NOT RETURNED. THE CONDITIONS IDENTIFIED DURING THE INVESTIGATION WERE ADDRESSED IN RECALL #Z-0580-2007 AND #Z-0581-2007. ALSO, SERVICE/MAINTENANCE OF THE DEVICE WAS NOT FOLLOWED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS. AN UPGRADE KIT WAS SENT TO ADDRESS THE CONDITION IDENTIFIED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A RESCUE ATTEMPT THE DEVICE ADVISED A SHOCK, BEGAN TO CHARGE AND THEN CANCELLED THE SHOCK. THE DEVICE THEN REPORTED A SERVICE MESSAGE AND POWERED OFF. ALTHOUGH, NO PATIENT DETAILS ARE AVAILABLE, 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-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death