BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 12364879 · Received August 25, 2021

    Report

    Report Number
    1937649-2021-00004
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Report Date
    September 15, 2021
    Manufacturer
    ELEKTA INC
    Product Code
    MUJ
    UDI-DI
    00858164002268
    PMA / PMN Number
    K190178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIVE ACTIONS TAKEN AS A RESULT OF THE INVESTIGATION: AN IMPORTANT FIELD SAFETY NOTICE (382-01-MON-017) WAS SENT TO ALL AFFECTED CUSTOMERS FROM 14 SEPTEMBER 2021 (ELEKTA REFERENCE #: (B)(4)). THE ISSUE WILL BE ADDRESSED IN A FIELD SAFETY MODIFICATION WHICH WILL BE RELEASED AS FOLLOWS: · MONACO 5.51.11 (FOR CUSTOMERS OUTSIDE OF CHINA) - EXPECTED BY DECEMBER 2021. · MONACO 5.40.04 (FOR CUSTOMERS IN CHINA) - EXPECTED BY MARCH 2022.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. WHEN THE UNITY (MR LINAC) PLAN IS IN OFFLINE MODE, THE ADAPT TO SHAPE PLAN WILL LOAD THE DAILY IMAGE SET AS PRIMARY AND THE REFERENCE IMAGE SET AS SECONDARY. THE USER DECIDED THEY WANTED TO CREATE A NEW EXTERNAL STRUCTURE USING AUTOMARGIN ON THE DAILY IMAGE SET. THE USER NAVIGATED TO THE AUTOMARGIN DIALOG, BUT THE USER DID NOT NOTICE THAT THE DIALOG DEFAULTED TO THE REFERENCE IMAGE SET. THE USER CREATED THE NEW EXTERNAL CONTOUR AND SAVED IT. THIS SAVED THE NEW EXTERNAL CONTOUR TO THE REFERENCE IMAGE SET BUT IT DID NOT FREEZE DOSES OR UNAPPROVED THE REFERENCE PLAN. WHEN USING THE AUTOMARGIN DIALOG THE USER CAN ENTER ANY LOADED STUDY ON THE DIALOG. IF THE USER USES A STUDY THAT IS NOT LOADED AS PRIMARY AND MAKE CHANGES, THE STUDYSET CHANGES ARE SAVED BUT ANY PLANS ASSOCIATED WITH THAT STUDY ARE NOT UPDATED. TO USE A PLAN AS A REFERENCE PLAN IN THE UNITY WORKFLOW IT MUST BE APPROVED, AND IT CANNOT BE FROZEN. IF THE USER EDITS THE EXTERNAL CONTOUR, THE PLAN SHOULD BE FROZEN BLOCKING IT FROM BEING USED AS A REFERENCE PLAN GOING FORWARD.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE MARGIN TOOL OVERWRITES THE REFERENCE STRUCTURE SET WITHOUT FREEZING DOSE. THE CUSTOMER WAS USING VERSION (B)(4) (MFR REPORT #: 1937649-2021-00003). DURING INTERNAL INVESTIGATION, ELEKTA FOUND THAT THIS THE ISSUE ALSO OCCURS IN VERSION (B)(4). WHICH IS A DIFFERENT 510K NUMBER (K190178).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263355 MONACO SYSTEM, PLANNING, RADIATION THERAPY TREATMENT MUJ ELEKTA INC MONACO 00858164002268

    Patients

    Seq Age Sex Outcome Treatment
    1