BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1191421 · Received September 26, 2008

    Report

    Report Number
    3003793371-2008-00005
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K010975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT USE OF MULTIPLE STATIC SEGMENT TECHNIQUE CAUSES INCORRECT MONITOR UNIT CALCULATIONS. THE DOCTOR CAN APPROVE THE DOSE DISTRIBUTION BECAUSE IT APPEARS CORRECT. HOWEVER, THE ECLIPSE SOFTWARE DOES NOT CALCULATE THE MU (DOSE) FOR THE CORRESPONDING FIELDS CORRECTLY. IT WAS DETERMINED THAT IF SUCH A PLAN IS DELIVERED, AN UNDER DOSAGE OF AS MUCH AS 50% AVERAGE DEPENDING ON THE MU FACTOR MIGHT OCCUR. A DISCREPANCY REPORT HAS BEEN INITIATED TO CORRECT THIS ISSUE IN A FUTURE SOFTWARE RELEASE. IN ADDITION, AN URGENT MEDICAL DEVICE CORRECTION NOTIFICATION WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF (B) (4). NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    VARIAN DISCOVERED THAT THE LEAF MOTION CALCULATOR WITHIN THE ECLIPSE DISTRIBUTED CALCULATION FRAMEWORK, V 8.2.22 INCORRECTLY CALCULATES MONITOR UNITS WHEN USING THE MULTIPLE STATIC SEGMENT TECHNIQUE/FEATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS H48

    Patients

    Seq Age Sex Outcome Treatment
    1