BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVER AED

    MDR report key: 1729968 · Received June 18, 2010

    Report

    Report Number
    3003521780-2010-00009
    Event Type
    Death
    Date Received
    June 18, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 21, 2010
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A NUMBER OF ATTEMPTS WERE MADE TO CONTACT THE END CUSTOMER, HOWEVER, NEITHER THE ACTUAL DEVICE INVOLVED IN THE INCIDENT NOR THE ELECTRONIC HISTORY RECORD HAS BEEN MADE AVAILABLE TO THE MANUFACTURER FOR EVAL. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE WAS CHARGING AND THEN CANCELLED THE SHOCK. IT WAS REPORTED THAT 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-100B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death