BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2476092 · Received January 31, 2012

    Report

    Report Number
    3003793371-2009-00024
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    November 18, 2009
    Report Date
    November 18, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PT 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 WAS SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED. (B)(4).

    Description of Event or Problem · 1

    AFTER REVISING THE TREATMENT PLAN, A RADIATION OVERDOSE OR UNDERDOSE COULD BE DELIVERED BECAUSE THE ACTUAL SOURCE TO SURFACE DISTANCE (SSD) VS THE PLANNED SSD IS NOT DISPLAYED TO THE USER DURING APPROVAL OR ON THE IN-ROOM DISPLAY AFTER THE REVISION IS MADE.

    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