BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2091280 · Received May 4, 2011

    Report

    Report Number
    3003793371-2011-00009
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 7, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER RECENTLY UPGRADED FROM VERSION 7.3 TO VERSION 10.0.34 AND WAS CONFUSED WITH THE PLANNED SSD AND CALCULATED SSD IN THE PLAN APPROVAL WIZARD. AFTER EXPLAINING TO HER THE DIFFERENCE AND RATIONAL OF THE TWO SSDS, SHE SHOWED ME A CASE WHERE THE PLANNED SSD ARE DIFFERENT THAN THE CALCULATED SSD. THIS PLAN HAS BEEN COPIED FROM ANOTHER PLAN WHERE THE PLANNED SSDS WERE POPULATED. THE PROBLEM IS WHEN COPYING A PLAN WITH PLANNED SSDS (ACTUAL SSD IN OLDER VERSIONS), THE PLANNED SSDS ARE SUPPOSED TO BE CLEARED AUTOMATICALLY ON THE COPIED PLAN. THIS WORKS PERFECTLY IF WE COPY A PLAN FROM A PLANNING APPROVED PLAN. HOWEVER, IF THE ORIGINAL PLAN'S STATUS, WHERE THE PLANNED SSDS ARE POPULATED IN THE FIELDS, IS CHANGED TO UNAPPROVED, THEN THE PLAN IS COPIED, THE NEWLY PASTED PLAN'S FIELDS PLANNED SSDS ARE NOT CLEARED OUT. THEY CONTAIN THE SAME VALUES AS IN THE ORIGINAL PLAN. IF THE GANTRY ANGLE, FOR EXAMPLE, IS CHANGED THE PLANNED SSD IS STILL NOT CLEARED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1