BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1299182 · Received December 4, 2008

    Report

    Report Number
    3003793371-2008-00006
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    March 23, 2007
    Report Date
    December 4, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K010975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT DURING CONVERSION FROM ECLIPSE 7.3.10 TO ECLIPSE 8, THE (B) (4) WEDGE ORIENTATION IS NOT MAINTAINED. THE ECLIPSE SOFTWARE LABELING WAS ISSUED WITHOUT A WARNING MESSAGE RELATING TO THE PRESERVATION OF USER SELECTED VALUES FOR THE ORIENTATION OF (B) (4) WEDGES, THE WEDGE LIMITS AND SAD VALUES FOR ELEKTA MACHINES, AND COLLIMATOR OPERATING LIMITS FOR SATURNE MACHINES, WHEN THE SOFTWARE VERSION IS UPGRADED. VARIAN IS PROVIDING NOTIFICATION OF THIS ISSUE TO OUR CUSTOMERS BY WAY OF AN URGENT MEDICAL DEVICE CORRECTION LETTER. INCLUDED WITH THIS NOTIFICATION IS A COPY OF THE CORRECTED WARNINGS PAGE OF THE INSPIRATION PLATFORM CUSTOMER RELEASE NOTES. IN ADDITION, ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF (B) (4). NO F/U REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    FOLLOWING TREATMENT, IT WAS IDENTIFIED BY THE THERAPIST THAT THE WEDGE DIRECTION APPEARED TO BE WRONG. THE PHYSICS STAFF THEN IDENTIFIED THE INCORRECT WEDGE ORIENTATION. THE CUSTOMER REPORTS THAT ABOUT 3 CM OF BREAST TISSUE WAS UNDER DOSED 3 - 5% FOR ONE FRACTION.

    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