BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONACO

    MDR report key: 6803108 · Received August 18, 2017

    Report

    Report Number
    1937649-2017-00004
    Event Type
    Injury
    Date Received
    August 18, 2017
    Report Date
    August 18, 2017
    Manufacturer
    ELEKTA INC..
    Product Code
    MUJ
    PMA / PMN Number
    K151233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MONACO IS WORKING AS DESIGNED AND INTENDED. THE DOSE CALCULATION PROPERTIES ARE CONSISTENTLY DISPLAYED TO THE USER IN THE GRAPHICAL USER INTERFACE, DICOM EXPORTS, AND THE REPORTS. IN THIS SPECIFIC CASE, A THIRD PARTY MONITOR UNIT CALCULATOR WAS USED AND THE INCORRECT DEPTH WAS ENTERED FOR CALCULATION.

    Description of Event or Problem · 1

    THE USER IS CREATING MONTE CARLO ELECTRON CALCULATIONS IN MONACO TO DETERMINE THE ISODOSE LINE AND COVERAGE OF TARGET VOLUMES ONLY, MU'S FROM MONACO ARE DISREGARDED AND CALCULATED IN THIRD PARTY SOFTWARE. THE USER REPORTED THAT THE FUNCTIONS AROUND BOLUS ADDITION IN MONACO ARE NOT THE SAME AS BOLUS FUNCTIONS IN XIO. IN PARTICULAR ADDITION OF BOLUS IN MONACO RESULTS IN A LARGER EFFECTIVE DEPTH TO THE DOSE CALCULATION POINT, IF THIS POINT IS LOCATED AT THE DISTAL EDGE OF THE DOSE DISTRIBUTION WITHOUT BOLUS, ADDITION OF BOLUS WILL INCREASE THE EFFECTIVE DEPTH OF THE CALCULATION POINT POTENTIALLY INCREASING THE MU'S REQUIRED TO ACHIEVE THE DESIRED DOSE AT THE CALCULATION POINT. ACCORDING TO THE SITE PHYSICIST 6 PATIENTS WERE MISTREATED AND THE MAGNITUDE OF DOSE ERRORS RANGED FROM 5% TO 20% FOR THESE PATIENTS. THIS COULD RESULT IN SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584990 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ ELEKTA INC..

    Patients

    Seq Age Sex Outcome Treatment
    1 Other