BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1881425 · Received October 19, 2010

    Report

    Report Number
    3003793371-2010-00030
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    CUSTOMER WAS APPROVING A PLAN AND NOTICED THAT THE PLANNED SSD DID NOT AGREE WITH THE ACTUAL SSD. IT WAS ASCERTAINED THAT THE PLAN WAS COPIED FROM A PREVIOUSLY APPROVED PLAN AND THE GANTRY ANGLE WAS CHANGED. CUSTOMER DOES NOT LIKE THIS FUNCTIONALITY AND REQUESTED A COMPLAINT BE LODGED. THE WORK AROUND IS TO ENSURE THE PLANNED SSD MATCHES THE ACTUAL SSD. CUSTOMER FEELS THAT THIS SHOULD BE AUTOMATICALLY BE DONE. NO PATIENT INJURY REPORTED, AND NO PATIENT DATA PROVIDED.

    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