BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO RTP SYSTEM

    MDR report key: 4252091 · Received November 14, 2014

    Report

    Report Number
    1937649-2014-00016
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS,INC.
    Product Code
    MUJ
    PMA / PMN Number
    K132971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MONACO DOES NOT CORRECTLY KEEP TRACK OF WHAT ELECTRON APPLICATOR WAS USED FOR DOSE CALCULATION. THERE WAS NO MISTREATMENT REPORTED BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737973 MONACO RTP SYSTEM SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ IMPAC MEDICAL SYSTEMS,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1