BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1616737 · Received February 23, 2010

    Report

    Report Number
    3003793371-2010-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    November 19, 2009
    Report Date
    November 19, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT WHEN A PLAN REVISION IS CREATED AND THE SSD (SOURCE SURFACE DISTANCE) IS CHANGED, AND THE REVISED PLAN IS APPROVED VIA RT CHART, THE ACTUAL SSD VS. PLANNED SSD IS NOT DISPLAYED TO THE USER DURING APPROVAL, NOR IS THE IN-ROOM DISPLAY SSD UPDATED WITH THE NEW PLANNED SSD. THE IN-ROOM DISPLAY IS THEN USED FOR PATIENT TREATMENT SET-UP AT DIFFERENT DISTANCE THAN CALCULATED. THIS SCENARIO COULD RESULT IN A TREATMENT OVERDOSE OR UNDER DOSE, DEPENDENT UPON THE PLANNED VS. TREATED DISTANCE. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER CREATED A REVISION OF AN ELECTRON PLAN IN RT CHART AND THEN CHANGED PLAN TO SSD (SOURCE SURFACE DISTANCE) IN ECLIPSE AND RECALCULATED MUS. THEN CUSTOMER MOVED BACK TO RT CHART AND PLAN APPROVED IN RT CHART. WHEN REVIEWING PLAN PRIOR TO PLAN APPROVAL, THE CUSTOMER NOTICED THAT SSD IN RT CHART DID NOT MATCH PLANNING SSD. BECAUSE, CUSTOMER CHANGED SSD IN REVISED ELECTRON PLAN, THEN APPROVED IN RT CHART, THE PLAN APPROVAL DIALOG BOX DID NOT COME UP SHOWING DIFFERENCE IN ACTUAL AND PLANNING SSDS. NO PATIENT INJURY REPORTED, AND NO PATIENT DATA PROVIDED. THE DISCREPANCY WAS CAUGHT PRIOR TO TREATMENT.

    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