BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIEVER AED

    MDR report key: 2989664 · Received February 27, 2013

    Report

    Report Number
    3003521780-2013-00003
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE ELECTRONIC HISTORY FILE FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE ACTUAL DEVICE WAS NOT RETURNED. THE INVESTIGATION DETERMINED THAT THE END CUSTOMER BELIEVES THAT THE USER MAY HAVE POWERED OFF THE DEVICE. REVIEW OF THE DEVICE'S ELECTRONIC HISTORY FILE INDICATES THAT THE DEVICE WAS POWERED OFF IN AN ORDERLY MANNER, INDICATING THAT THE DEVICE PERFORMED AS DESIGNED AND THAT THE USER POWERED OFF THE DEVICE, POSSIBLY INADVERTENTLY. BASED ON THESE FINDINGS, THIS MDR IS BEING FILED FOR OPERATOR ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT AN AED WAS DEPLOYED FOR A RESCUE ATTEMPT AND THAT AFTER THE PADS WERE PLACED ON THE PT, THE DEVICE POWERED OFF. IT WAS REPORTED THAT THE PT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84098 REVIEVER AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death