BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 1951877 · Received January 5, 2011

    Report

    Report Number
    1951877
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 4, 2011
    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 ERROR MESSAGE - "NO VIABLE FLOW" WOULD NOT ARM - THIS ERROR MESSAGE CAME UP PRIOR TO PROCEDURE NOT DURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA INJECTOR, CONTRAST, DISPOSABLE HAND CONTROL ACCESSORY DXT MEDRAD, INC. AVA500 HC M946310

    Patients

    Seq Age Sex Outcome Treatment
    1 *