BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX (TRUEBEAM)

    MDR report key: 2192552 · Received July 1, 2011

    Report

    Report Number
    2916710-2011-00079
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC.
    Product Code
    IYE
    PMA / PMN Number
    K092871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR APPROPRIATE, AS THIS REPORTED MALFUNCTION, SHOULD IT RECUR, MAY POTENTIALLY RESULT IN SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE TRUEBEAM APPLICATION RECEIVED UNHANDLED EXCEPTION ERROR AT THE END OF A TREATMENT, INDICATING THE APPLICATION NEEDED TO CLOSE. THE TRUEBEAM BECAME UNRESPONSIVE AND SHIFT>CONTROL>ALT> R, WOULD RECOVER THE DATA BUT WE WOULD END UP WITH SAME ERROR WHEN ATTEMPTING TO CLOSE THE PT. WE WERE UNABLE TO PROCEED WITH OTHER TREATMENTS WITHOUT CLEARING THE RECOVERY SESSION FOLDER MANUALLY. THE CUSTOMER'S COMPLAINT IS AS FOLLOWS: ALTHOUGH THE PT WAS TREATED SUCCESSFULLY, DUE TO THE ERROR, THERE WAS NO MEANS TO RECOVER AND THE TREATMENT DATA WAS LOST AS A RESULT. WHEN THE APPLICATION BECOMES UNRESPONSIVE, THERE NEEDS TO BE A MEANS TO ALWAYS BE ABLE TO HAVE A RECORD THAT CAN BE IMPORTED INTO ARIA WITH ACCURATE TREATMENT DATA. IMAGE ONLY PLANS ARE NOT POSSIBLE ON TRUEBEAM. THERE WAS NO SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT.

    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