BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWISSRAY DIGITAL

    MDR report key: 924347 · Received September 28, 2007

    Report

    Report Number
    MW5003956
    Event Type
    Malfunction
    Date Received
    September 28, 2007
    Date of Event
    February 20, 2007
    Report Date
    February 22, 2007
    Manufacturer
    SWISSRAY INTERNATIONAL INC.
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCIDENT INVOLVING SWISSRAY DIGITAL X-RAY UNIT AS PER X-RAY TECHNICIAN AT OUR FACILITY. HE INFORMED US THAT HE WAS SETTING THE SYSTEM IN TABLE MODE AND MOVING THE BUCKY ASSEMBLY TO THE HIGHEST POINT TO ALLOW THEM TO SETUP A PT TO IMAGE THE ELBOW REGION. AFTER THE DESIRED SET POINT WAS REACHED, HE PROCEEDED TO THE WORKSTATION (WITH DEMOGRAPHICS WHEN HE NOTICED THAT THE C-ARM BEGAN TO MOVE ON IT'S OWN IN A NEGATIVE (LEFT HAND) DIRECTION AND PROCEEDED TOWARDS THE FLOOR. HE IMMEDIATELY TRIPPED THE EMERGENCY STOP AND THE SYSTEM SHUTDOWN WITH THE BACK OF C-ARM JUST ABOVE FLOOR LEVEL. THE PT WAS NOT IN THE ROOM AT THE TIME OF THE INCIDENT. IMAGING TECHS CALLED, 2 MORE RUNAWAY SITUATIONS EXPERIENCED DURING THE REPAIR TROUBLESHOOTING PROCESS, BUT NO ONE WAS IN THE IMMEDIATE AREA OF C-ARM MOVEMENT POSITON. THE PROBLEM WAS FOUND TO BE AN INTERMITTENT OPERATION OF A BRAKE ASSEMBLY LOCATED WITH THE C-ARM DRIVE MOTOR ASSEMBLY. THIS ASSEMBLY HAS BEEN ORDERED AND CURRENTLY AWAITING ARRIVAL TO FACILITY TO PROCEED WITH REPAIRS. ROOM HAS BEEN ISOLATED TO REPAIR TECHNICIANS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWISSRAY DIGITAL X-RAY UNIT KPR SWISSRAY INTERNATIONAL INC. DDR MULTISYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR