BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO RTP SYSTEM

    MDR report key: 4327139 · Received December 12, 2014

    Report

    Report Number
    1937649-2014-00017
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    December 12, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS,INC.
    Product Code
    MUJ
    PMA / PMN Number
    K132971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. THE DEFECT WILL BE FIXED IN A LATER VERSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IF A WEDGE IS ADDED TO A BEAM ON MONACO, THE WEDGE NORMALIZATION GETS SET TO OPEN NORMALIZATION. THIS IS HARD CODED INSIDE MONACO; THUS, THE USER CAN NOT CHANGE IT. FOR ABSOLUTE DOSE PLANS, THE WEDGE NORMALIZATION SHOULD ALWAYS BE SET TO WEDGED NORMALIZATION. WHEN DOSE IS CALCULATED ON XIO, THERE IS A LARGE DOSE DIFFERENCE BETWEEN WEDGE DOSE CALCULATED USING WEDGE NORMALIZATION AND WEDGE DOSE CALCULATED USING OPEN NORMALIZATION. ON XIO, THE SOURCE INDEX DOES INDICATE THE OPEN WEDGE NORMALIZATION WAS USED; HOWEVER, THE MONACO SOURCE INDEX DOES NOT INDICATE THE TYPE OF WEDGE NORMALIZATION USED. THERE WAS NO MISTREATMENT REPORTED BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807338 MONACO RTP SYSTEM SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ IMPAC MEDICAL SYSTEMS,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1