BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 3994079 · Received August 6, 2014

    Report

    Report Number
    3994079
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HAND CONTROLLER FOR THE MEDRAD INJECTOR IS NOT FUNCTIONING. A NEW CONTROLLER IS USED FOR EACH CASE AND 3 OF THE HAND CONTROLLERS HAD TO BE SWITCHED OUT AT THE BEGINNING OF THE CASE BECAUSE THEY WOULD NOT INJECT OR FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460167 AVANTA INJECTOR AND SYRINGE, ANGIOGRAPHIC, HAND CONTROLLER DXT MEDRAD * 163194

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR