BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS RADIATION TREATMENT PLANNING SYS

    MDR report key: 89166 · Received May 2, 1997

    Report

    Report Number
    1937649-1997-00003
    Event Type
    Malfunction
    Date Received
    May 2, 1997
    Date of Event
    April 18, 1997
    Report Date
    April 29, 1997
    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

    CUSTOMER CREATED A TREATMENT PLAN DEFAULT BEAM SET-UP AND SAVED IT WITH INHOMOGENEITY CORRECTION TURNED "ON". SUBSEQUENTLY THE USER RECALLED THE STORED BEAM SET-UP INTO A PLAN WITH INHOMOGENEITY CORRECTION TURNED "OFF". THE TREATMENT PLAN CALCULATED WITH INHOMOGENEITY CORRECTION "ON". THIS RESULTED IN AN EFFECTIVE DEPTH GREATER THAN PHYSICAL DEPTH BECAUSE OF A HIGH DENSITY REGION IN THE PATH OF ONE BEAM. THE PLANNER NOTED THE DISCREPANCY AND NO PATIENT WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS RADIATION TREATMENT PLANNING SYS RADIATION TREATMENT PLANNING SYSTEM KPQ COMPUTERIZED MEDICAL SYSTEMS, INC. 9200 RELEASE 1.4.1

    Patients

    Seq Age Sex Outcome Treatment
    1 *