BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2190648 · Received July 27, 2011

    Report

    Report Number
    2916710-2011-00095
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 1, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K100890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VARIAN RA CLINICAL REP CALLED THE CUSTOMER ON (B)(4) 2011 AT 3:33 PM EST. THE PHYSICIAN CONFIRMED THAT THE PT WAS NOT HARMED OR TOUCHED BY THE GANTRY. THE PHYSICIAN REPORTED THAT "THE PT COULD HAVE BEEN INJURED IF THEY WERE NOT WATCHING". ALTHOUGH, THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER SITE INFORMED A VARIAN FIELD SERVICE REP (FSR) THAT A WEEK EARLIER, THE GANTRY MOVED UNEXPECTEDLY DURING TREATMENT AND COLLIDED WITH THE PT ON THE TABLE. ACCORDING TO THE THERAPIST, THE PT NEEDED TO BE FILMED AT A SPECIFIC GANTRY ANGLE. THE FILM WAS TAKEN AND THE TREATMENT FIELD WAS READY TO BE ADMINISTERED. THE THERAPIST CLAIMS THAT THE GANTRY ROTATION POSITION SHOULD HAVE BEEN SATISFIED AS ITS CURRENT POSITION AND SHOULD NOT HAVE MOVED. THE PRESSING OF THE TWO BUTTONS ON THE DEDICATED KEYBOARD WAS JUST A USUAL QUICK CHECK REQUIRED BY THE SYSTEM TO MAKE SURE ALL AXES ARE IN POSITION. WHEN THE THERAPIST PRESSED THE MOTION ENABLE BUTTON AND DOUBLE ARROW ON THE DEDICATED KEYBOARD TO CLEAR THE JAWS, ETC., THE GANTRY MOVED INTO THE PT. CUSTOMER DECLINED TO PROVIDE ANY PT INFO. THE VARIAN FSR REMAINED ON SITE TO MONITOR OPERATION BUT NOTHING OUT OF THE ORDINARY OCCURRED. THE SITE STATED THAT SINCE THE REPORTED INCIDENT, THEY HAVE BEEN EXTREMELY CAREFUL AND HAVE NOT SEEN THE SAME OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H14

    Patients

    Seq Age Sex Outcome Treatment
    1