BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVER, AED

    MDR report key: 1197343 · Received October 9, 2008

    Report

    Report Number
    3003521780-2007-00010
    Event Type
    Death
    Date Received
    October 9, 2008
    Date of Event
    January 15, 2007
    Report Date
    November 2, 2007
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Removal / Correction Number
    Z-0580-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED INT HE INCIDENT WAS EVALUATED. BASED ON THE EVALUATION, THE SOFTWARE INCORRECTLY CLEARED A LOW BATTERY WARNING, AS 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.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THERE WAS A REPORT THAT, NOT DURING PT USE, A DEVICE WOULD NOT POWER ON. ON (B)(6) 2007, REVIEW OF THE DEVICE AND IT'S ELECTRONIC HISTORY FILE IDENTIFIED THAT DURING A DEPLOYMENT OF THE DEVICE, ON (B)(6) 2007, A SHOCK WAS CANCELED DURING A RESCUE ATTEMPT. THE ELECTRONIC HISTORY FILE INDICATES THAT DURING THE RESCUE ATTEMPT, THE DEVICE ADVISED A SHOCK, REPORTED A SERVICE CODE MESSAGE, AND SHUT DOWN. THE DEVICE WAS POWERED ON A SECOND TIME, ADVISED A SHOCK, REPORTED A SERVICE CODE MESSAGE, AND SHUT DOWN. ON THE THIRD ATTEMPT, THE DEVICE WAS POWERED ON, AND 4 SHOCKS WERE ADMINISTERED BEFORE A REPLACE BATTERY MESSAGE WAS REPORTED AND THE DEVICE POWERED OFF. IT WAS REPORTED THAT THE PT 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 84 YR Death