BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX - TRUEBEAM

    MDR report key: 1976605 · Received January 26, 2011

    Report

    Report Number
    2916710-2010-00165
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 19, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAILY QA CHECK, THE USER FOUND THE IMAGING ISOCENTER OFF BY 2MM. THE DATA LOG INDICATED THAT ISOCAL (ISOCENTER CALIBRATION) HAD BEEN DISABLED WITHOUT ANY WARNING OR MESSAGE. NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1