BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS RADIATION TREATMENT PLANNING SYSTEM

    MDR report key: 102376 · Received June 30, 1997

    Report

    Report Number
    1937649-1997-00004
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    June 16, 1997
    Report Date
    June 30, 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

    AFTER CREATING A TREATMENT PLAN HAVING TWO BEAMS WITH CUSTOMIZED PORTS ATTACHED (ONE WAS COPY-PARALLEL-OPPOSED TO THE OTHER), STORING THE PLAN AND THEN RECALLING IT, THE USER NOTICED THE PORTS HAD THEIR ORIENTATIONS REVERSED. THE COPY-PARALLEL-OPPOSED BEAM SHOULD HAVE ITS PORT MIRRORED RELATIVE TO THE FIRST BEAM. INSTEAD, THE PORT ON THE ORIGINAL BEAM WAS MIRRORED RELATIVE TO ITS CORRECT POSITION AND THE COPIED PORT WAS ORIENTED AS THE PORT ON THE FIRST BEAM SHOULD HAVE BEEN. THIS WAS FOUND DURING ROUTINE TREATMENT PLAN CHECKS BY THE MEDICAL PHYSICIST. NO PTS WERE TREATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *