BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN LINAC

    MDR report key: 11748288 · Received April 29, 2021

    Report

    Report Number
    3011233554-2021-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 29, 2021
    Manufacturer
    VIEWRAY, INC.
    Product Code
    IYE
    PMA / PMN Number
    K170751
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE DOES NOT AFFECT SYSTEMS USING THE ENGLISH USER INTERFACE (UI); IT ONLY AFFECTS SITES USING THE (B)(6), GERMAN OR ITALIAN UI. INVESTIGATION IDENTIFIED THE ROOT CAUSE AS FOLLOWS: THE TREATMENT PLANNING AND DELIVERY SYSTEM (TPDS) COMMUNICATES THE GATING ALGORITHM SETTINGS TO THE TREATMENT DELIVERY COMPUTATION UNIT (TDCU) USING AN .XML FILE. THE VALUES FOR "% ROI" AND "CONFIDENCE THRESHOLD" ARE DOCUMENTED AS NUMERICAL VALUES. THESE VALUES ARE THEN CONVERTED TO TEXT IN AN .XML FILE. THE COMMUNICATION MESSAGE IS THEN SENT FROM THE DELIVERY UI TO THE TDCU USING THE EUROPEAN DECIMAL NOTATION WHEN TPDS IS SET TO (B)(6), ITALIAN OR GERMAN LANGUAGES. THE NUMERICAL VALUE DOES NOT GET CONVERTED TO THE VALUES EXPECTED BY THE TDCU. THE TDCU IS EXPECTING A NEUTRAL DECIMAL NOTATION AS IN THE ENGLISH UI.

    Description of Event or Problem · 1

    A USER OF VIEWRAY'S MRIDIAN LINAC SYSTEM REPORTED AN OCCURRENCE WHERE A CHANGE TO THE REGION OF INTEREST (ROI) MADE IN THE "EDIT TRACKING" WINDOW WAS NOT REFLECTED IN TREATMENT DELIVERY IN THE (B)(6) LANGUAGE USER'S INTERFACE (UI) VERSION. THE ROI ALWAYS DEFAULTS TO 5%. THE SITE FURTHER REPORTED THE CONFIDENCE THRESHOLD DOES NOT WORK AT ANYTHING OTHER THAN DEFAULT 50% IN (B)(6) LANGUAGE UI VERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645148 MRIDIAN LINAC RADIATION THERAPY IYE VIEWRAY, INC. 20000-1

    Patients

    Seq Age Sex Outcome Treatment
    1