BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1193131 · Received October 7, 2008

    Report

    Report Number
    2916710-2008-00043
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K926321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. BASED ON THE PRELIMINARY EVALUATION OF THE CUSTOMER'S REPORT, IT HAS BEEN DETERMINED THAT THE ISSUE CAN POTENTIALLY CAUSE A SERIOUS INJURY OR DEATH. THE REPORT IS STILL UNDER INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, VARIAN WILL SUBMIT A FOLLOW UP REPORT WITH OUR FINDINGS. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DIFFERENT TYPES OF MOVEMENT WITH THE LINEAR ACCELERATOR MACHINE WITHOUT THE ACTIVATION FROM THE MACHINE PENDANTS. REPORTED GANTRY MOVEMENT, ISOCENTRIC ROTATION OF THE COUCH AND VERTICAL MOVEMENT FOR COUCH. THE ISSUE OCCURRED AT THE END OF THE TREATMENT. DURING EVALUATION BY VARIAN'S FIELD SERVICE PERSONNEL, THE ALLEGED REPORT COULD NOT BE REPRODUCED. WHEN THE MOTION ENABLE BAR (MEB) IS PRESSED, MOVEMENT OCCURRED WITHOUT "TARGET", BUT THOSE MOVEMENTS STOP IF THE MEB'S ARE RELEASED ON THE PENDANT. SPEED IS "NORMAL" FOR COUCH MOVEMENT, BUT SOME GANTRY MOVEMENT WAS REPORTED TO A "JERK" MOTION (FROM ONE SIDE TO OTHER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS CL-600C

    Patients

    Seq Age Sex Outcome Treatment
    1