BEUDAMED
    FDA Adverse Event Summary report: N

    MONACO RTP SYSTEM

    MDR report key: 3993464 · Received July 25, 2014

    Report

    Report Number
    1937649-2014-00010
    Date Received
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K132971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MONACO VERSION 3.30.00.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GANTRY ANGLE DISPLAYS 60 DEGREES, BUT DOSE IS CALCULATED FOR 170 DEGREES ANGLE. THERE WAS NO INDICATION OF MISTREATMENT. THE ALLEGATION COULD NOT BE INVESTIGATED, NOR A ROOT CAUSE DETERMINED, BECAUSE OF LACK OF DATA. THERE IS NO EVIDENCE OF A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436782 MONACO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM MUJ IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1