BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX

    MDR report key: 1961440 · Received January 6, 2011

    Report

    Report Number
    2916710-2010-00155
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    December 15, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC. ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K092871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED INJURY IN THIS CASE. THIS ISSUE WAS ENCOUNTERED INTERNALLY BY VARIAN ENGINEERING DURING VERIFICATION TESTING. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION COULD POTENTIALLY RESULT IN MISTREATMENT CAUSE SERIOUS INJURY.

    Description of Event or Problem · 1

    WHILE VARIAN SQE WAS PERFORMING SYSTEM VERIFICATION WITH BUILD 1.5.7.3, THE FOLLOWING WAS OBSERVED: SYSTEM CRASHED DURING TREATMENT, THE MU DELIVERED WAS RECORDED AND SYSTEM WAS RESTARTED. THE RECOVERY SESSION LOADED WITH THE CORRECT MU DELIVERED. THE CANCEL TREATMENT BUTTON WAS PRESSED AND A "DOSE LIMITS MISSING WARNING" DIALOG BOX APPEARED. THE ISSUE IS THAT IF THE SYSTEM CRASHES DURING TREATMENT, THE PATIENT TREATMENT RECORDS ARE NOT SAVED. THERE IS NO MESSAGE TO USER TO MANUALLY IMPORT THE TREATMENT RECORDS. WHEN THE SAME PATIENT RECORDS ARE OPENED AGAIN MU COUNT PREVIOUSLY DELIVERED IS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY MX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS INC. ONCOLOGY SYSTEMS 1.5.7.3

    Patients

    Seq Age Sex Outcome Treatment
    1