BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVER AED

    MDR report key: 1273584 · Received December 18, 2008

    Report

    Report Number
    3003521780-2008-00028
    Event Type
    Death
    Date Received
    December 18, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 19, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT AND THE INTERNAL DEVICE USAGE HISTORY WAS REVIEWED. THE REVIEW DETERMINED THAT THE DEVICE WOULD NOT INITIALLY POWER ON DUE TO A COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, WHEN THE BUTTON WAS PRESSED, THE DEVICE DID NOT POWER ON. THE BATTERY PACK WAS EJECTED AND REINSERTED. THE ON BUTTON WAS DEPRESSED AGAIN AND THE DEVICE POWERED ON. IT WAS REPORTED THAT ONCE THE DEVICE POWERED ON, IT PERFORMED PROPERLY FOR THE REMAINDER OF THE INCIDENT. IT IS BELIEVED THAT THE PATIENT DID NOT SURVIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death