BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJI FCR GO MOBILE X-RAY

    MDR report key: 2487828 · Received March 7, 2012

    Report

    Report Number
    MW5024569
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 7, 2012
    Manufacturer
    FUJI FILM MEDICAL
    Product Code
    IZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FROM (B)(6), DIAGNOSTIC IMAGING TECHNOLOGIST. THE MACHINE (FCR GO MOBILE X-RAY) WAS ACTING FINE FROM STARTUP TILL WE GOT TO THE PT'S ROOM TO PERFORM THE EXAM. ONCE THE X-RAY MACHINE CROSSED THE THRESHOLD OF THE ROOM, IT MADE A CLICKING NOISE AS IF IT JUST STARTED MOVING AND FROM THERE WE WERE UNABLE TO DRIVE IT. I THEN TRIED TO MOVE THE MACHINE OUT OF THE DOORWAY BUT I HAD NO CONTROL OVER IT. AFTER ABOUT 2 MINUTES OF TRYING TO MOVE THE PORTABLE, IT BEGAN TO PUSH ME BACKWARDS VERY SLOWLY. USING ALL MY WEIGHT, THERE WAS NO WAY TO STOP IT. AFTER IT PUSHED ME ACROSS THE HALLWAY, WE TURNED IT COMPLETELY OFF AND THAT FINALLY PUT THE MACHINE IN PARK AND REMAINED IN NEUTRAL. WE THEN CONTACTED THE BMET, AND THEY TOOK THE MACHINE FROM THERE. FROM THE MEDICAL MAINTENANCE DEPT, THIS PRODUCT QUALITY DEFICIENCY REPORT IS FOR THE FUJI FCR GO MOBILE X-RAY UNIT. THIS UNIT HAS A DANGEROUS MALFUNCTION AND WHEN POWERED ON STARTS TO DRIFT IN REVERSE. THIS DANGEROUS ACTION CAN ONLY BE STOPPED BY THE OPERATOR BY PRESSING THE EMERGENCY STOPS OR TURNING THE UNIT OFF IF THEY ARE AT THE DRIVE CONTROL SIDE OF THE UNIT (REAR). I HAVE ALREADY HAD THIS UNIT RUN INTO THE SHOP DOOR DURING TROUBLESHOOTING BECAUSE I WAS AT THE TUBE HEAD SIDE (FRONT) WHEN IT DECIDED TO MALFUNCTION AND COULD NOT REACH THE STOP BUTTONS OR KEY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJI FCR GO MOBILE X-RAY FUJI GO IZL FUJI FILM MEDICAL FRC-MB 101

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability