BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 10229215 · Received July 3, 2020

    Report

    Report Number
    1937649-2020-00013
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 3, 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 ISSUE THAT WAS FOUND INTERNALLY AT ELEKTA INC. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. WHEN A NEW STRUCTURE IS ADDED AND A FORCED ELECTRON DENSITY IS DEFINED, THE DOSE IS NOT REMOVED. ALTHOUGH THE DOSE DISTRIBUTION WILL NOT ACCOUNT FOR THE NEW STRUCTURE AND FORCED DENSITY, THE STRUCTURES SPREADSHEET WILL INDICATE THAT THE NEW CONTOUR AND FORCED DENSITY HAVE BEEN APPLIED. THIS INCONSISTENCY COULD RESULT IN INCORRECT CLINICAL DECISIONS THAT COULD RESULT IN DOSE ERRORS GREATER THAN 5%. THE DEFECT WILL BE FIXED IN A FUTURE RELEASE.

    Description of Event or Problem · 1

    DURING AN INTERNAL INVESTIGATION AT ELEKTA INC.,WHEN ADDING A NEW STRUCTURE WITH VOLUME AND FORCE ED, THE DOSE IS NOT REMOVED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694525 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ ELEKTA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1