BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN IX-S

    MDR report key: 2482010 · Received March 5, 2012

    Report

    Report Number
    2482010
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 16, 2012
    Report Date
    March 2, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS SCHEDULED FOR EXTERNAL BEAM RADIATION THERAPY ON A MEDICAL LINEAR ACCELERATOR (LINAC). AS PART OF THE SET UP FOR TREATMENT, ORTHOGONAL X-RAY IMAGES OF THE PATIENT ARE ACQUIRED. THE LINAC INVOLVED HAS AN ON-BOARD IMAGING (OBI), CONSISTING OF AN X-RAY SOURCE AND DIGITAL X-RAY DETECTOR, SYSTEM MOUNTED ON THE LINAC GANTRY. THE SOURCE AND DETECTOR ARE MOUNTED ON RETRACTABLE ARMS WHICH ARE EXTENDED FOR IMAGING AND RETRACTED FOR TREATMENT. AFTER TAKING ORTHOGONAL X-RAY IMAGES, THE X-RAY TUBE ARM WAS DIRECTLY OVER THE PATIENT. THERAPISTS WERE OUTSIDE THE ROOM AT THE TREATMENT CONSOLE. THERAPISTS STARTED TO RETRACT THE OBI AND NOTICED DEVICE ERRORS AS WELL AS THE DEVICE GOING IN THE WRONG DIRECTION. UPON ENTERING THE ROOM, THE X-RAY TUBE SUPPORT ASSEMBLY WAS OBSERVED TO HAVE DESCENDED TO WITHIN 6 INCHES OF THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE MOTION WAS NOT EXPECTED AND WAS TRACED TO A FAILED MOTOR ASSEMBLY IN THE X-RAY TUBE SUPPORT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN IX-S LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS, INC. IX-S *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES