BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD® STELLANT CT INJECTION SYSTEM

    MDR report key: 8270065 · Received January 23, 2019

    Report

    Report Number
    8270065
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    December 20, 2018
    Report Date
    December 21, 2018
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BAYER HAS SENT OUT A WINDOWS 10 SOFTWARE UPDATE THAT WAS "PUSHED". ALSO DURING THIS TIME, A GENERATOR TEST WAS SCHEDULED. THE BAYER CERTEGRA WORK STATION WAS SHUTDOWN AND WAS RESTARTED AFTER THE GENERATOR TEST. WHEN THE BAYER CERTEGRA WORK STATION BOOTED UP, IT COMES UP WITH A MESSAGE "YOUR PC RAN INTO A PROBLEM AND NEEDS TO RESTART. WE'LL RESTART FOR YOU". THE SYSTEM THEN REBOOTS AND DISPLAYS THE MESSAGE AGAIN CAUSING AN ENDLESS LOOP AND RENDERING THE INJECTOR USELESS. UPON INITIAL INSPECTION FROM OUR TEAM, IT APPEARS THE WINDOWS 10 UPDATE MAY HAVE CAUSED SOME SORT OF DISCONNECT WITH SOME OF THE DRIVERS. WITH BOTH OF THE HOSPITAL CT'S CERTEGRA WORK STATIONS DOWN, A MESSAGE WAS SENT OUT TO CLINICAL STAFF INDICATING THE HOSPITAL IS UNABLE TO PERFORM CTA EXAMS. THIS INCLUDES CTA HEAD, NECK, CHEST OR ABDOMEN. IF THE PATIENT IS A MRI CANDIDATE, MRA MAY BE A VIABLE OPTION. MANUFACTURER RESPONSE FOR INJECTOR, CONTRAST, BAYER MEDRAD STELLAN W/CERTEGRA WORK STATION (PER SITE REPORTER). SERVICE CALL WAS MADE TO MFG AND WE WILL BE NOTIFIED ON ANY UPDATES AS SOON AS POSSIBLE. OUR INJECTORS ARE DOWN FOR OVER 24 HOURS AS TIME OF THIS SUBMISSION. MANUFACTURER RESPONSE FOR INJECTOR, CONTRAST, MEDRAD CERTEGRA INJECTOR (PER SITE REPORTER). CALL WAS MADE TO BAYER. CASE NUMBER WAS GIVEN. THE MANUFACTURER INFORMED HOSPITAL THEY ARE WORKING ON THE ISSUE AND WILL UPDATE AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62488 MEDRAD® STELLANT CT INJECTION SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BAYER MEDICAL CARE, INC. STELLANT CT

    Patients

    Seq Age Sex Outcome Treatment
    1