BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX - TRUEBEAM

    MDR report key: 2221387 · Received August 16, 2011

    Report

    Report Number
    2916710-2011-00111
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K092871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGEST 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. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING TREATMENT OF A GATED FIELD, BOTH CONSOLE SCREENS LOCKED UP. THE CUSTOMER WAS UNABLE TO SEE THE MU UPDATING OR THE MLC LEAVES MOVING. MU BEEPING SOUNDS AND BACKUP COUNTER INDICATED THAT THE MACHINE CONTINUED TO DELIVER BEAM. THE CUSTOMER TERMINATED THE BEAM USING THE BEAM OFF BUTTON. THE TREATMENT CONSOLE INDICATED A DELIVERED DOSE OF 171 OUT OF 252 MU, THE BACKUP COUNTER INDICATED A DELIVERED DOSE OF 249 OUT OF 252 MU. AFTER PHYSICS HAD BEEN NOTIFIED, CONTROL OF THE TREATMENT CONSOLE RESUMED. THE PHYSICIST PERFORMED A SCREEN CAPTURE AND AFTER THE SCREEN CAPTURE, THE DISPLAY ON THE CONSOLE WORKSTATION UPDATED THE DELIVERED MU TO MATCH THE BACKUP COUNTER. THE PT WAS CLOSED AND VERIFIED IN ARIA. THE DOSE RECORDED IN ARIA MATCHED THE BACKUP COUNTER AND THE UPDATED DISPLAY ON THE CONSOLE WORKSTATION. THE CUSTOMER IS CONCERNED ABOUT THE LOSS OF CONTROL ON THE CONSOLE WORKSTATION DURING TREATMENT AND THE INABILITY DURING THIS TIME, TO VERIFY THE MACHINE IS PROPERLY DELIVERING DOSE. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1