BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVER AED

    MDR report key: 1638451 · Received March 17, 2010

    Report

    Report Number
    3003521780-2010-00006
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    May 10, 2009
    Report Date
    February 17, 2010
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF THE ACTUAL DEVICE AND THE DEVICE'S ELECTRONIC HISTORY RECORD INDICATES THAT THE DEVICE WAS NOT PROPERLY MAINTAINED ACCORDING TO MANUFACTURER SPECIFICATIONS PRIOR TO THE EVENT. DURING THE EVENT, THE DEVICE ATTEMPTED TO DELIVER THERAPY, HOWEVER, IT WAS UNABLE TO, DUE TO HIGH PT IMPEDANCE. THE HIGH PT IMPEDANCE WAS LIKELY DUE TO AN ISSUE WITH THE DEFIBRILLATION ELECTRODES, EXTERNAL TO THE DEVICE (I.E. DRY ELECTRODES). THE ELECTRODES WERE NOT RETURNED FOR EVALUATION AND WITHOUT THEM, NO DEFINITIVE CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    A DEVICE WAS RECEIVED FOR SERVICE FOR AN UNRELATED ISSUE AND REVIEW OF ITS ELECTRONIC HISTORY RECORD SHOWED THAT ON (B) (6) 2009, THE DEVICE WAS UNABLE TO DELIVERY THERAPY AND THAT IT ISSUED A HIGH PT IMPEDANCE WARNING. THE PT OUTCOME IS UNK.

    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