BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVER VIEW AED

    MDR report key: 3761313 · Received April 11, 2014

    Report

    Report Number
    3003521780-2014-00009
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AED'S ELECTRONIC HISTORY HAS NOT BEEN PROVIDED AND NO ADDITIONAL INFORMATION IS KNOWN ABOUT THE AED OR THE EVENT. THE INVESTIGATION IS CURRENTLY IN-PROCESS AND NO CONCLUSIONS HAVE BEEN MADE AT THIS TIME. BASED ON THE OUTCOME OF THE INVESTIGATION, SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT A FEMALE WORKER WAS FOUND SLUMPED OVER HER DESK (ESTIMATED TIME DOWN 5 MINUTES) AND A CPR TRAINED CO-WORKER STARTED CPR AND DEPLOYED AN AED. THE CPR TRAINED CO-WORKER REPORTED THAT THE AED DID NOT SHOCK THE PT, BUT THOUGHT IT SHOULD HAVE. IT WAS ALSO REPORTED THAT EMTS THEN ARRIVED, GAVE THE PT DRUGS, DEFIBRILLATED HER AND GOT A PULSE. THE PT WAS REPORTED TO BE IN THE HOSPITAL ALIVE, BUT THE LONG TERM PROGNOSIS IS UNCLEAR. AS LIMITED INFORMATION IS AVAILABLE, THIS EVENT IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220360 REVIVER VIEW AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-C2300EN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization