BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 499404 · Received November 19, 2003

    Report

    Report Number
    MW1030288
    Event Type
    Malfunction
    Date Received
    November 19, 2003
    Date of Event
    October 31, 2003
    Report Date
    November 19, 2003
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VARIAN MEDICAL SYSTEMS TREATMENT PLANNING SYSTEM HAS A SOFTWARE DEFECT WHICH RESULTED IN A DYNAMIC MULTILEAF COLLIMATOR TO BE DROPPED FROM THE TREATMENT FIELDS WHEN MOVED FROM PLANNING TO RECORD & VERIFY DATABASE SYSTEM. RESULT IN A HIGHER DOSE PER FRACTION THAN INTENDED FOR SIX FRACTIONS. HUMAN OVERSIGHT CAUGHT THE PRBLEM AND PT TREATMENTS WERE CORRECTED AND ADJUSTED TO BRING BIOLOGICAL EQUIVALENT DOSE TO AN EFFECTIVE TUMOR CONTROL DOSE. CLINICAL OUTCOME IS EQUIVALENT TO SIMILAR TYPES OF TREATMENTS SINCE IT WAS CAUGHT EARLY IN TREATMENT CYCLE. PT DID NOT SUFFER ANY SERIOUS INJURY AS A RESULT OF THIS SOFTWARE DEFECT. PT AND MANUFACTURER WERE ALERTED TO PROBLEM WITHIN 24 HOURS OF DISCOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM IYE VARIAN MEDICAL SYSTEMS 6.1.67 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR