BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 1944596 · Received December 14, 2010

    Report

    Report Number
    1944596
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 29, 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 WORKED FOR A COUPLE OF INJECTIONS AND THEN AN ERROR MESSAGE STARTED TO APPEAR AND THE SYSTEM DISARMED EACH INJECTION AFTER THE FIRST TWO. UNPLUGGED AND PLUGGED BACK IN SEVERAL TIMES AND THE DEVICE STILL CONTINUED WITH THE ERROR MESSAGE. REBOOTED SYSTEM; A NEW CONTROLLER WAS THEN USED AND WORKED FINE.DOCTOR IS FRUSTRATED WITH THE SYSTEM AND THE PROBLEMS WITH THE HAND CONTROLLERS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA INJECTOR, CONTRAST, DISPOSABLE HAND CONTROL ACCESSORY DXT MEDRAD, INC. AVA 500 HC M945510

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR