BEUDAMED
    FDA Adverse Event Summary report: N

    REVIVER AED

    MDR report key: 2112452 · Received March 22, 2011

    Report

    Report Number
    3003521780-2011-00007
    Date Received
    March 22, 2011
    Report Date
    February 21, 2011
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END CUSTOMER REPORTED THE DEVICE DID NOT ADVISE A SHOCK DURING USE. NEITHER THE DEVICE NOR THE ELECTRONIC HISTORY RECORD HAS BEEN RETURNED TO ASSIST WITH THE INVESTIGATION. ADDITIONAL ATTEMPTS ARE BEING MADE TO GATHER THIS INFORMATION AND FOLLOW-UP MDR WILL BE FILED AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, A DEVICE DID NOT ADVISE A SHOCK TO A PT. NO RESCUE ATTEMPT OR PT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVIVER AED SEMI-AUTOMATIC EXTERNAL DEFBRILLATOR MKJ DEFIBTECH, LLC DDU-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1