BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX

    MDR report key: 2234395 · Received July 21, 2011

    Report

    Report Number
    2916710-2011-00093
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    IYE
    PMA / PMN Number
    K092871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SITE REPORTS SEVERAL MLC GAP ADJUSTMENTS IN THE TRUEBEAM. THE CUSTOMER REPORTS THAT WHEN USING ENERGIES OF 6FFF AND 10FFF, THE BEAM MODELING IS OKAY - NO PROBLEMS. WHEN THEY PERFORM QA FOR SMALL FIELD SIZES (LESS THAN 12 X 12 CM), THEY NEED A LARGE DOSIMETRIC LEAF GAP (0.25CM). FOR BIG FIELDS, SUCH AS PELVIC GYN AND HEAD AND NECK, THE QAS PASS WITH SMALLER DLG (0.14). THE CUSTOMER REPORTS THAT THEY HAD SEVERAL GAP ADJUSTMENTS IN THE TRUEBEAM. THE FIRST ONE WAS MADE BY THE ENGINEER INSTALLER, BECAUSE THEY WERE HAVING BEAM OFF, DUE THE MLC FAULTS AND SINCE THEN, THEY NEVER GET A VERY GOOD AGREEMENT BETWEEN ECLIPSE AND IMRT QA IN TRUEBEAM. INITIALLY, THEIR PICKET FENCE TEST WAS SHOWING THAT THE MLC WAS SKEWED, THE ENGINEERS THEN ADJUSTED THE MLC WHICH IMPROVED THE PICKET FENCE RESULTS. AT THIS POINT, THEIR SMLC DELIVERY (PLANNED IN PINNACLE) SHOWS GOOD AGREEMENT WITH THE PLANNING SYSTEM AND TRUEBEAM. THEY COMPARE SMLC CALCULATIONS FROM PINNACLE AND ECLIPSE, WHICH ALSO SHOWS GOOD AGREEMENT. THE ONLY PROBLEM IS DMLC DELIVERY ON TRUEBEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY MX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC H19

    Patients

    Seq Age Sex Outcome Treatment
    1