BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVER AED

    MDR report key: 2579897 · Received May 15, 2012

    Report

    Report Number
    3003521780-2012-00002
    Event Type
    Death
    Date Received
    May 15, 2012
    Date of Event
    February 12, 2012
    Report Date
    April 16, 2012
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC HISTORY FILE FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE ACTUAL DEVICE WAS NOT RETURNED. REVIEW OF THE ECG RECORD DEMONSTRATES THAT THE VICTIM WAS IN A SHOCKABLE RHYTHM. THE AED CORRECTLY ADVISED AND DELIVERED A SHOCK, WHICH CONVERTED THE RHYTHM TO NORMAL SINUS RHYTHM. THE VICTIM THEN RE-FIBRILLATED. SUBSEQUENTLY, THE AED DID NOT RECOMMEND A SHOCK DUE TO THE MORPHOLOGY OF THE ECG WAVEFORM, WHICH DID NOT CONSISTENTLY SATISFY THE CRITERIA FOR DEFIBRILLATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT AN AED WAS USED DURING A RESCUE ATTEMPT AND THAT A SHOCK WAS RECOMMENDED AND DELIVERED AFTER THE FIRST ANALYSIS PERIOD. THERE WERE TWO SUBSEQUENT ANALYSIS PERIODS WHERE THE DEVICE DID NOT ADVISE A SHOCK. THE PT WAS NOT RESUSCITATED.

    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 Death