BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 1946145 · Received December 31, 2010

    Report

    Report Number
    1946145
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    September 22, 2010
    Report Date
    December 29, 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

    ERROR STATING EARLY TERMINATION. RE-ARMED AND IT WORKED ONCE, THEN RECEIVED ANOTHER ERROR MESSAGE FOR CONTROLLER TO BE CONNECTED. UNPLUGGED DEVICE AND PLUGGED IT BACK IN AND THEN RE-TRIED WITH NO RESPONSE. A NEW HAND CONTROLLER WAS USED AND IT WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA INJECTOR, CONTRAST, DISPOSABLE HAND CONTROL ACCESSORY DXT MEDRAD INC. * M939360

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR