BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 1547596 · Received November 17, 2009

    Report

    Report Number
    3003521780-2009-00017
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    October 3, 2009
    Report Date
    October 19, 2009
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RESULTS - THE ACTUAL DEVICE HAS BEEN EVALUATED. EVALUATION RESULT, ERROR HANDLING FAULT DURING CHARGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE ANALYZED, ADVISED A SHOCK BE ADMINISTERED AND BEGAN TO CHARGE. IT THEN CANCELLED THE SHOCK, RE-ANALYZED, ADVISED A SHOCK AND BEGAN TO CHARGE. THE DEVICE THEN CANCELLED THE SHOCK, REPORTED A SERVICE MESSAGE AND POWERED OFF. THE PT WAS TRANSFERRED TO A SEC 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-100E-NL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening