BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 1944607 · Received December 14, 2010

    Report

    Report Number
    1944607
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 3, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    HAND CONTROLLER ON INJECTOR FOR CONRAST STOPPED WORKING DURING THE CASE. UNPLUGGED AND REBOOTED SEVERAL TIMES. A NEW DEVICE WAS THEN USED AND WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA INJECTOR, CONTRAST, DISPOSABLE HAND CONTROL ACCESSORY DXT MEDRAD, INC. AVA 500HC M944870

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR