BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2475735 · Received January 31, 2012

    Report

    Report Number
    3003793371-2008-00012
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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 F/U REPORTS ARE ANTICIPATED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER HAS AN ECLIPSE PLAN REPORT THAT SHOWS A DIFFERENCE BETWEEN THE ACTUAL SSD AND PLANNED SSD. THE REASON WHY THE REPORT SHOWED A DIFFERENCE BETWEEN THE PLANNED SSD AND THE ACTUAL SSD IS THE FACT THE PLAN HAS BEEN COPIED FROM AN ALREADY PLANNING APPROVED PLAN. THE FIELDS IN THE COPIED PLAN HAVE A DIFFERENT GANTRY ANGLE AS THE ORIGINAL PLAN, THEREFORE A DIFFERENT PLANNED SSD. THE PLAN REPORT HAS BEEN PRINTED BEFORE THE PLANNING APPROVAL PROCESS, WHICH EXPLAINS THE DIFFERENCE SEEN ON THE PLAN REPORT. THE PLANNING APPROVAL PROCESS WILL WARN THE USER THAT THE PLANNED SSD AND ACTUAL SSD ARE DIFFERENT; THIS HAS BEEN EXPLAINED TO THE CUSTOMER. THE CUSTOMER UNDERSTANDS THE CONCEPT IN THE SYSTEM BUT IS IN DISAGREEMENT WITH THE SYSTEM DESIGN. NO PT INJURY REPORTED, AND NO PT 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