BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 2217305 · Received July 13, 2011

    Report

    Report Number
    2916710-2011-00083
    Event Type
    Other
    Date Received
    July 13, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K100890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN'S INVESTIGATION HAS DETERMINED THAT THE THERAPIST'S INTENTION, WAS TO ROTATE THE GANTRY MANUALLY FROM OUTSIDE THE ROOM TO THE "HEAD UP" POSITION FROM 180 DEGREES (VARIAN SCALE) FOR PT DISMOUNT; INSTEAD OF STOPPING AT 180 DEGREES AS INTENDED, CONTINUED ON-WARD UNTIL STRIKING THE PT AT A GANTRY ANGLE 135 DEGREES. THE COUCH HEIGHT AT THE TIME WAS 118 CM AND THE COUCH WAS ALSO ROTATED BY 90 DEGREES, PLACING THE PT DIRECTLY IN THE PATH OF THE GANTRY'S TRAVEL. THE MACHINE WAS UNDAMAGED AND ALTHOUGH THEY RECEIVED A VELOCITY CHECK ERROR FOLLOWING THE COLLISION, THE ERROR WAS SUBSEQUENTLY CLEARED BY THE THERAPIST "RELOADING THE FIELD AND PRESSING ENTER". THERE WAS NO MALFUNCTION OF THE MACHINE, THE MACHINE WAS UNDER THE DIRECT CONTROL (MANUAL MOTION) OF THE THERAPIST AT THE TIME, WHO ADMITS "HE WAS NOT PAYING ATTENTION AND CONTINUED ROTATING THE GANTRY UNTIL THE PT YELLED AFTER SHE WAS HIT IN THE ABDOMEN". THERE IS NO ALLEGATION OF A MACHINE MALFUNCTION AND THE THERAPIST IS CLEARLY AWARE OF THE ERROR. VARIAN HAS DISTRIBUTED A PRECAUTIONARY NOTICE (PNL) TO ALL APPLICABLE CUSTOMERS REGARDING THE POTENTIAL FOR GANTRY COLLISIONS DURING REMOTE AUTO MOTION. VARIAN HAS INITIATED A CAPA TO FURTHER ADDRESS GANTRY COLLISIONS AND FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. ALL CORRECTIVE ACTION REGARDING THIS ISSUE WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADDITIONAL F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT AFTER COMPLETION OF PT TREATMENT, THE COUCH WAS AT THE 90 DEGREE POSITION AND THE GANTRY WAS AT 220 DEGREES. FROM OUTSIDE THE TREATMENT ROOM, THE THERAPIST STARTED ROTATING THE GANTRY BACK UP TO STOP AT 180 DEGREES. HE STATED THAT HE WAS NOT PAYING ATTENTION AND CONTINUED ROTATING THE GANTRY UNTIL THE PT YELLED UPON BEING HIT IN THE ABDOMEN. THEY STOPPED ROTATING THE GANTRY WENT INTO THE ROOM, DISENGAGED THE COUCH AND PULLED THE PT FORWARD. THE GANTRY WOULD NOT MOVE DO TO A HWFA MESSAGE. THE HWFA WAS "VELOCITY CHECK ERROR 30". THE THERAPIST STATED THAT HE GOT THE HWFA TO CLEAR BY RELOADING THE FIELD AND PRESSING ENTER. THERE IS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS EVENT. THE THERAPIST STATED THAT AFTER THEY REMOVE THE PT FROM THE TABLE, THE PT WAS FINE AND JUST ASKED FOR A DRINK OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H29

    Patients

    Seq Age Sex Outcome Treatment
    1