BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2600433 · Received May 23, 2012

    Report

    Report Number
    3003793371-2012-00005
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 25, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A MALFUNCTION IN THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MISMATCH IN DISPLAYED REFERENCE POINT DOSE IN EXTERNAL BEAM PLANNING COMPARED TO THE DOCUMENTED DOSE IN PLAN ORGANIZER AND RT CHART REFERENCE POINT TAB FOR THE SAME REFERENCE POINT IN AN IMRT PLAN. 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