BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 6154072 · Received December 8, 2016

    Report

    Report Number
    1937649-2016-00013
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Report Date
    December 7, 2016
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    UDI-DI
    00858164002169
    PMA / PMN Number
    K151233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST

    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.

    Description of Event or Problem · 1

    CONTOURS ARE NOT HANDLED CORRECTLY IF THE CT DATASET CONTAINS SLICES WITH DICOM Z COORDINATES OF XX.X50MM. IF THE CT DATA CONTAIN SLICES THAT OCCUR AT POSITIONS OF XX.X50MM, THERE CAN BE PORTIONS OF THE VOLUME WHERE THERE IS A MISMATCH BETWEEN THE CONTOUR GRAPHICS SHOWN ON THE SCREEN AND THE CONTOUR DATA USED DURING THE OPTIMIZATION AND CALCULATION OF DOSE. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO ACTUAL MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804774 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ IMPAC MEDICAL SYSTEMS, INC. 00858164002169

    Patients

    Seq Age Sex Outcome Treatment
    1