BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI PATIENT DISPOSABLE HAND CONTROLLER

    MDR report key: 1791996 · Received August 2, 2010

    Report

    Report Number
    1791996
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 2, 2010
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    MEDRAD WAS FULLY FUNCTIONAL AND AFTER TWO SUDDEN SYSTEM SHUTDOWNS THE HAND CONTROLLER STOPPED WORKING AND HAD TO TO BE CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MULTI PATIENT DISPOSABLE HAND CONTROLLER HAND CONTROLLER, INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT MEDRAD * M939360

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER THERAPIES