BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 10082806 · Received May 22, 2020

    Report

    Report Number
    1937649-2020-00009
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 22, 2020
    Manufacturer
    ELEKTA INC.
    Product Code
    MUJ
    PMA / PMN Number
    K183037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. BOLUS EXISTS IN THE REFERENCE PLAN AND IT IS DEFINED AS USER. DURING THE ATS ONLINE WORKFLOW, THE BOLUS IS CLEARED BY DESIGN TO FORCE THE USER TO RECREATE IT SINCE THE PATIENT OUTLINE MIGHT HAVE CHANGED. AFTER DOING THAT, THE PLAN IS CREATED, BUT THE BOLUS IS NOT ASSIGNED TO THE BEAMS IN THE BEAM SPREADSHEET FOR BOTH 3D AND IMRT. IN ADDITION, THE USER DOES NOT HAVE THE ABILITY TO REASSIGN THE BOLUS TO THE BEAM(S) AT THIS POINT. IF THE USER DOES NOT DETECT THAT BOLUS HAS NOT BEEN CONSIDERED IN THE DOSE CALCULATION, AND BOLUS IS ADDED DURING TREATMENT, THE DOSE DELIVERED WILL NOT MATCH THE DOSE DISPLAYED. UNDERDOSES COULD BE GREATER THAN 5%. THIS IS AN INTERNAL INVESTIGATION AT ELEKTA INC. AND THERE WERE NO PATIENTS INVOLVED. THE CORRECTIVE ACTION TAKEN AS A RESULT OF THIS INVESTIGATION IS THAT THE ISSUE WILL BE FIXED IN A FUTURE MONACO VERSION 5.51.10.

    Description of Event or Problem · 1

    DURING AN INTERNAL INVESTIGATION AT ELEKTA INC. WHEN USING BOLUS ON THE REFERENCE PLAN, THE SYSTEM DETECTS THAT DURING THE ATS ONLINE WORKFLOW THE STRUCTURE BOLUS THAT WAS DEFINED AS 'USER' IS MISSING AND FORCES THE USER TO RECREATE THE BOLUS ONLINE. AFTER RECREATING THE BOLUS ONLINE, THE PLAN IS CREATED BUT THE BOLUS IS NOT ASSIGNED TO THE BEAMS IN THE BEAM SPREADSHEET FOR BOTH 3D AND IMRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547821 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ ELEKTA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1