BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVER AED

    MDR report key: 3763244 · Received April 3, 2014

    Report

    Report Number
    3003521780-2014-00008
    Event Type
    Death
    Date Received
    April 3, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 4, 2014
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC HISTORY FROM THE AED IDENTIFIED THAT IT WAS PLACED IN SERVICE ON (B)(4) 2012 AND WAS FUNCTIONING PROPERLY, SUCCESSFULLY PERFORMING ITS SELF-TESTS WITH NO SERVICE CODES OR WARNINGS INDICATING A UNIT MALFUNCTION. AN EVENT WAS RECORDED ON (B)(4) 2014 IN 2 PARTS, THE FIRST PART LASTING 99 SECONDS, AND THE SECOND PART LASTING 85 SECONDS DURING WHICH TIME THE AED READ THE PT IMPEDANCE AS OPEN FOR THE ENTIRETY OF THE EVENT; AS IF THE PADS WERE EITHER NOT PLUGGED IN OR NOT PROPERLY APPLIED TO THE PT. THE AED, BATTERY PACK AND AN UNOPENED SET OF DEFIBRILLATION PADS WERE RETURNED FOR EVAL. THE USER OF THE AED REPORTED THAT THE PADS USED DURING THE EVENT WERE DISCARDED AND NO LOT INFO IS KNOWN. THE EVAL OF THE RETURNED AED AND BATTERY PACK, WHICH INCLUDED VISUAL INSPECTIONS OF THE AED CONNECTIONS AND CIRCUITRY, AS WELL AS FUNCTIONAL TESTING OF AED WHILE BEING CONNECTED TO A PT SIMULATOR, DID NOT IDENTIFY A PROBLEM WITH THE AED OR BATTERY PACK WHICH ARE FUNCTIONING AS DESIGNED. THE AED'S VOICE WAS NOTED AS SOUNDING LOUD AND CLEAR WITH NO "RINGING" OBSERVED. THE DEVICE USER WAS CONTACTED ON (B)(4) 2014 AND WAS QUESTIONED ABOUT THE EVENT AND THE "RINGING" SOUND. HE DESCRIBED THE RINGING AS CHIRPING. WE REVIEWED THE AED'S ELECTRONIC HISTORY FOR THIS EVENT WHICH WOULD HAVE PROMPTED THE USER TO BEGIN CPR AFTER 90 SECONDS AND WOULD HAVE EMITTED A CPR METRONOME TONE TO PACE THE USER DELIVERING CPR. WE DEMONSTRATED THE CPR TONE FOR THE USER AND QUESTIONED HIM IF THAT WAS THE "RINGING" THAT HE REPORTED. HE STATED HE COULD NOT RECALL THE "RINGING" SOUND. BASED ON THE RESULTS OF THE INVESTIGATION TO DATE, THIS MDR IS BEING FILED FOR USER ERROR - USER NOT PROPERLY APPLYING THE DEFIBRILLATION PADS TO THE PT; SINCE THE PT DID NOT SURVIVE.

    Description of Event or Problem · 1

    ON (B)(4) 2014, IT WAS REPORTED THAT DURING A RESCUE ATTEMPT BY A FITNESS CLUB EMPLOYEE, AN AED WAS POWERED ON, THE PADS WERE APPLIED TO THE PT, AND THAT THE AED BEGAN "RINGING" FOR ONE MINUTE, AT WHICH TIME EMS ARRIVED AND TOOK OVER THE RESCUE WITH THEIR EQUIPMENT. IT WAS REPORTED THAT THE PT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200658 REVIVER AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death