BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVER AED

    MDR report key: 2560201 · Received May 1, 2012

    Report

    Report Number
    3003521780-2012-00001
    Event Type
    Injury
    Date Received
    May 1, 2012
    Date of Event
    March 31, 2012
    Report Date
    April 2, 2012
    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

    EVAL SUMMARY: RESULT - REVIEW OF THE AED'S ELECTRONIC HISTORY RECORD FOR THE ACTUAL RESCUE ATTEMPT INDICATES THAT THE USER PRESSED THE SHOCK BUTTON AND THAT THE AED ATTEMPTED TO DELIVER A SHOCK, HOWEVER, THE AED WAS UNABLE TO DELIVER ENERGY TO THE PT LOAD. THE AED WAS RETURNED TO ASSIST WITH THE INVESTIGATION AND EXTENSIVE TESTING HAS BEEN PERFORMED ON THE AED. THE ISSUE IDENTIFIED IN THE COMPLAINT HAS NOT BEEN REPRODUCED AND THE AED IS PERFORMING TO SPECIFICATION. THE ISSUE THAT WAS IDENTIFIED MAY INVOLVE THE DEFIBRILLATION ELECTRODES, EXTERNAL TO THE DEVICE, OR WITH THE PLACEMENT OF THE ELECTRODES ON THE PT. HOWEVER, THE ELECTRODES WERE NOT RETURNED FOR EVAL AND ANY FURTHER CONCLUSION CANNOT BE MADE AT THIS TIME.

    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 NOT DELIVERED WHEN THE SHOCK BUTTON WAS PRESSED. THE PT WAS TRANSFERRED TO A SECOND DEFIBRILLATOR AND THERAPY WAS REPORTED TO HAVE BEEN DELIVERED. PT OUTCOME IS UNK, HOWEVER, IT WAS REPORTED THAT THE PT WAS BREATHING WHEN HE WAS TRANSFERRED TO THE AMBULANCE.

    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 Life Threatening