BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD® STELLANT CT INJECTION SYSTEM

    MDR report key: 7955881 · Received October 11, 2018

    Report

    Report Number
    7955881
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    April 1, 2018
    Report Date
    September 27, 2018
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RADIOLOGY TECH WAS PREPARING FOR IMAGING AND THERE WAS NO POWER TO THE INJECTOR. MANUFACTURER RESPONSE: FOR INJECTOR, (BRAND NOT PROVIDED) (PER SITE REPORTER) SENT A REPRESENTATIVE OUT TO THE FACILITY TO EVALUATE. VENDOR REPLACED THE POD ASSEMBLY AND INJECTOR WAS PUT BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796169 MEDRAD® STELLANT CT INJECTION SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BAYER MEDICAL CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1