BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS RADIATION TREATMENT PLANNING SYS

    MDR report key: 89207 · Received May 5, 1997

    Report

    Report Number
    1937649-1997-00002
    Event Type
    Malfunction
    Date Received
    May 5, 1997
    Date of Event
    April 15, 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

    THE CUSTOMER ADDED A BEAM ON A RADIATION TREATMENT PLAN, ADDED A CUSTOMIZED PORT, DID A COPY PARALLEL OPPOSED TO ADD A SECOND BEAM WITH CUSTOMIZED PORT AND SAVED THAT SET-UP UNDER TREATMENT PLAN DEFAULT. WHILE IN THE SAME PLAN, THE CUSTOMER EDITED THE CUSTOMIZED PORT ON THE ORIGINAL BEAM AND NOTICED THAT THE EDITS WERE NOT COPIED TO THE PORT ON THE BEAM WHICH HAD BEEN COPY PARALLEL OPPOSED EARLIER. THIS ONLY HAPPENS ON THE ORIGINAL PLAN USING THE TREATMENT PLAN DEFAULT. SUBSUEQUENT USE ON OTHER PLANS SHOWS NO PROBLEMS. NO PTS WERE 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 *