BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS RADIATION TREATMENT PLANNING SYSTEM

    MDR report key: 155400 · Received March 9, 1998

    Report

    Report Number
    1937649-1998-00002
    Event Type
    Malfunction
    Date Received
    March 9, 1998
    Date of Event
    February 23, 1998
    Report Date
    March 5, 1998
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT WHEN VALIDATING THE PHYSICS DATA, AS REQUIRED BY THE FOCUS RTP SYSTEM, THEY NOTED THE RELATIVE DENSITY FIGURES IN THE PHYSICS DATA TABLE FOR SELECTED MATERIALS WERE INCORRECT. THE PROBLEM WAS CREATED BY CMS LOADING INCORRECT NUMBERS INTO THE TABLE. THERE IS A WORK-AROUND FOR CUSTOMERS. NO PTS WERE TREATED. THIS ONLY AFFACTS PHOTON DOSE CALCULATION DONE USING THE FFT ALGORITHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS RADIATION TREATMENT PLANNING SYSTEM RTP: SYSTEM KPQ COMPUTERIZED MEDICAL SYSTEMS, INC. 9200 RELEASE 2.0.0 ONLY

    Patients

    Seq Age Sex Outcome Treatment
    1 *