BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2556272 · Received April 24, 2012

    Report

    Report Number
    3003793371-2012-00002
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    March 26, 2012
    Report Date
    March 26, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIST

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO VARIAN THAT FOLLOWING AN ECLIPSE TREATMENT PLANNING SYSTEM SOFTWARE UPGRADE FROM (B)(4), IT HAS BEEN OBSERVED FOR SEVERAL PTS THAT THE BEAMS EYE VIEW IS NOT DISPLAYED CORRECTLY AND THE FIELD CALCULATION IS NOT CORRECT IF THE COLLIMATOR IS 90 DEGREES OR 270 DEGREES. IT WAS REPORTED THAT PRIOR TO THE SOFTWARE UPGRADE, THE USER HAD CREATED SOME PLANS FOR SEVERAL PTS IN ORDER TO EVALUATE THE DOSE CALCULATION AFTER THE UPGRADE, THESE PLANS WERE CALCULATED IN AN OLD VERSION AND HAD NOT BEEN APPROVED (FOR TREATMENT). 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