BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBTECH REVIVER AED

    MDR report key: 597397 · Received April 22, 2005

    Report

    Report Number
    77101-2005-00002
    Event Type
    Malfunction
    Date Received
    April 22, 2005
    Date of Event
    March 30, 2005
    Report Date
    April 20, 2005
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEFIBRILLATION PADS WERE PLACED ON THE PATIENT (PATIENT DETAILS NOT AVAILABLE), THE DEVICE ON/OFF BUTTON WAS PRESSED, AND THE DEVICE DID NOT RESPOND. THE ON/OFF BUTTON WAS PRESSED AGAIN, AND THE DEVICE DID NOT RESPOND; AT WHICH TIME, A MEDICAL RESPONSE TEAM ARRIVED ON THE SCENE AND ASSUMED TREATMENT OF THE PATIENT. PATIENT WAS NOT RESUSCITATED. DEVICE MALFUNCTION DID NOT AFFECT PATIENT OUTCOME, ACCORDING TO THE REPORT, DUE TO LACK OF PATIENT VIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBTECH REVIVER AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening