BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 12239189 · Received July 28, 2021

    Report

    Report Number
    1937649-2021-00002
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Report Date
    July 28, 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 · 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. THE INVESTIGATION FOUND THAT IF A COUCH IS REMOVED WHILE A PLAN IS LOADED, AND THEN ADDED BACK TO THE STUDYSET WHEN THE PLAN IS UNLOADED, IT IS POSSIBLE TO CALCULATE DOSE WITH THE COUCH UNASSIGNED TO THE BEAMS. A MONACO UNITY PLAN CAN BE CALCULATED WITHOUT INCLUDING THE COUCH ATTENUATION. THE DOSE DISTRIBUTION SHOWN IN MONACO WITHOUT THE COUCH ATTENUATION WILL NOT MATCH THE DOSE DELIVERED TO THE PATIENT WHEN THE COUCH IS PRESENT. THIS ISSUE HAPPENS WHEN ONLY A PARTICULAR WORKFLOW IS BEING USED WITH MONACO AND ELEKTA UNITY AND NOT WITH ELEKTA CONVENTIONAL LINAC. A FIELD CORRECTIVE ACTION NOTICE WILL BE ISSUED. AN IMPORTANT FIELD SAFETY NOTICE (IFSN 382-01-MON-019) WILL BE ISSUED. THE DEFECT WILL BE FIXED IN A FUTURE RELEASE OF MONACO WHICH IS ESTIMATED TO BE RELEASED JUNE 2022.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE ELEKTA UNITY COUCH BECAME UNASSIGNED IN THE TREATMENT AIDS TAB FOR A REFERENCE PLAN. THE CUSTOMER WAS USING VERSION 5.40.01. (MFR REPORT #: 1937649-2021-00001). DURING INTERNAL INVESTIGATIONS IT WAS ASCERTAINED THAT THE ISSUE ALSO OCCURS IN VERSION 5.51.10, WHICH IS A DIFFERENT 510K NUMBER (K190178).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137795 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ ELEKTA INC. Monaco 00858164002268

    Patients

    Seq Age Sex Outcome Treatment
    1