BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX

    MDR report key: 1963510 · Received January 12, 2011

    Report

    Report Number
    2916710-2010-00158
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    November 16, 2010
    Report Date
    December 15, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K092871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TROUBLESHOOTING, THE NETWORK CONFIGURATION AND SPEED WERE CHECKED AND TESTED. CONFIGURATION OF HOSP SWITCH VS. MACHINE SWITCH WAS INCORRECT, CAUSING NETWORK DELAYS OF APPROX 100X SPEED. SCREEN SHOT OF TREATMENT SCREEN WAS CAPTURED, SHOWING ONLY 1ST FIELD WAS COMPLETED. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IN AN AUTOMATED TREATMENT SEQUENCE, ALL 8 FIELDS WERE TREATED WITHOUT USER INTERVENTION, BUT ONLY ONE FILE WAS RECORDED IN (B)(4). A MESSAGE WAS RECEIVED STATING THAT NOT ALL FIELDS WERE TREATED. THERE WAS NO REPORT OF PT INJURY AND NO PT DATA WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1