BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVER AED

    MDR report key: 2193886 · Received August 2, 2011

    Report

    Report Number
    3003521780-2011-00015
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 5, 2011
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Removal / Correction Number
    Z-2064-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. RESULT CODE: THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS DUE TO A FALSE FAILURE OF THE SOFTWARE CHECK DUE TO INTERFERENCE DURING CHARGING. A REPORT OF CORRECTION FOR THIS ISSUE HAS BEEN FILED WITH FDA. SINCE THE INITIAL FILING OF THE COMPLAINT, THE AED'S SOFTWARE HAS BEEN UPGRADED TO ADDRESS RECALL Z-2064-2011 AND HAS BEEN PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT AN AED POWERED OFF DURING A RESCUE. THE DEVICE'S INTERNAL HISTORY RECORD WAS RECEIVED AND REVIEWED ON (B)(6) 2011. DURING THIS REVIEW, IT WAS DETERMINED THAT THE AED HAD BEEN DEPLOYED FOR A RESCUE ATTEMPT ON (B)(6) 2011 AND THAT 8 SHOCKS WERE DELIVERED, 1 SHOCK ABORTED, 2 SHOCKS DELIVERED AND THEN 2 SHOCKS ABORTED. THE DEVICE THEN REPORTED A SERVICE CODE AND POWERED OFF. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening