BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2587511 · Received May 14, 2012

    Report

    Report Number
    3003793371-2012-00003
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN PROVIDED THE CUSTOMER WITH AN IMMEDIATE WORK AROUND BY INSTRUCTING THE USER TO COPY AND PASTE THE ORIGINAL NON-SPLIT PLAN, DEFINED A PRIMARY REFERENCE POINT, RE-RUN OPTIMIZATION AND CALCULATE. THE CUSTOMER WAS ABLE TO APPROVE THE PLAN AND THE RESULTING SPLIT (#) PLAN HAD THE CORRECT MU ON THE SPLIT FIELDS. IN ADDITION, VARIAN PROVIDED A COPY OF THE CTB (CUSTOMER TECHNICAL BULLETIN) THAT DESCRIBES THE DEVICE BEHAVIOR. THIS ISSUE WAS PREVIOUSLY REPORTED ON MDR #3003793371-2009-00001. A PRODUCT NOTIFICATION LETTER WAS PROVIDED TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION HAS BEEN REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO F/U REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO VARIAN THAT THE MU ON IMRT PLAN WITH SPLIT FIELDS ARE DOUBLED. ACCORDING TO THE REPORT, THERE WAS NO PT ASSOCIATED WITH THIS EVENT. NO PT INJURY HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1