BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO RTP SYSTEM

    MDR report key: 3202210 · Received June 28, 2013

    Report

    Report Number
    1937649-2013-00001
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K110730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN SAMPLE COUCH PARAMETER FILES ARE EDITED, THE DENSITIES ALTERED AND "SAVE" IS SELECTED, THE SAMPLE FILES WILL BE UPDATED WITH THESE NEW, USER DEFINED DENSITIES. SUBSEQUENTLY, WHEN A SOFTWARE UPGRADE IS LOADED, THE MODIFIED COUCH DENSITIES IN THESE SAMPLE FILES WILL BE OVERWRITTEN WITH THE DEFAULT VALUE OF 1.000. THIS ERROR RESULTED IN A CLINICALLY INSIGNIFICANT TREATMENT DELIVERY DEVIATION FROM PLAN FOR ONE PT. CUSTOMER REPORTED THAT THE IMPACT WAS ANALYZED AND COULD BE COMPENSATED IN THE REST OF THE TREATMENT SO THE OVERALL OUTCOME WAS FINE. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295559 MONACO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM - MUJ MUJ IMPAC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK