BEUDAMED
    FDA Adverse Event Summary report: N

    REVIVER AED

    MDR report key: 2118973 · Received May 4, 2011

    Report

    Report Number
    3003521780-2011-00011
    Date Received
    May 4, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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 AED'S USAGE HISTORY RECORD INDICATES THAT THE 9-VOLT ACTIVE STATUS INDICATOR (ASI) BATTERY WAS FULLY DEPLETED ON (B)(6) 2008 AFTER PROVIDING WARNING INDICATIONS (BLINKING RED LED AND "CHIRPING" ALERT) FOR NEARLY A MONTH. CONSEQUENTLY, NO AUTOMATED SELF-TESTS WERE PERFORMED FOR THE 32 MONTHS PRECEDING THE ATTEMPTED RESCUE EFFORT, DURING WHICH TIME, THE RESCUE BATTERY BECAME LOW. HOWEVER, THE 9-VOLT BATTERY PACK WAS NOT REPLACED AND THE DEVICE REMAINED IN SERVICE. FOR THE RESCUE ATTEMPT ON (B)(6) 2011, SHOCKS WERE ABORTED DUE TO A LOW BATTERY CONDITION. THERE WAS A FAILURE TO SERVICE/MAINTAIN THE DEVICE ACCORDING TO MANUFACTURER RECOMMENDATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, A DEVICE WAS USED AND WHEN IT WAS POWERED ON, IT WOULD THEN POWER OFF. A SECOND DEFIBRILLATOR WAS APPLIED TO THE PT AND THE PT WAS REPORTED TO HAVE SURVIVED.

    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 60 YR Life Threatening