BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-ACCESS

    MDR report key: 495470 · Received November 6, 2003

    Report

    Report Number
    MW1030119
    Event Type
    Malfunction
    Date Received
    November 6, 2003
    Date of Event
    October 16, 2003
    Report Date
    November 6, 2003
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN THE PT'S FILE IN THE RECORD AND VERIFY SYSTEM THE GEOMETRIC PARAMETERS, INCLUDING THE MLC FIELD SHAPE, OF THE PT'S RIGHT LATERAL BEAM WERE LOADED INTO THE ANTERIOR BEAM. THERE WERE 16 PRIOR FRACTIONS DELIVERED WITH THE CORRECT ANTERIOR BEAM. THERE WAS NO HISTORICAL RECORD OF ANY FIELD CHANGES IN THE PT'S ELECTRONIC CHART, THERE WERE NO CHANGES REQUESTED BY THE RADIATION ONCOLOGIST NOR WERE ANY CHANGES TO THIS PT'S TREATMENT FIELDS IMPORTED BY THE PHYSICS STAFF. ONLY THE GEOMETRY BLOCK OF THE ANTERIOR FIELD WAS CHANGED. THE RADIATION INFO WAS CORRECT FOR THE ANTERIOR FIELD. SINCE THE GANTRY ANGLE WAS INCORRECT BY 90 DEGREES THE SOFTWARE CORRECTLY INHIBITED THE TREATMENT AND THE PROBLEM WAS FOUND BY THE THERAPIST. A NEW ANTERIOR BEAM WITH THE CORRECT GEOMETRY WAS CREATED AND THE PT TREATED PROPERLY. THE INCORRECT ANTERIOR FIELD WAS SAVED AND HIDDEN TO AVOID USE SO THAT THE VENDOR COULD INVESTIGATE. THE VENDOR WAS NOTIFIED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-ACCESS RADIATION ONCOLOGY MANAGEMENT SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR