BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 1960778 · Received December 17, 2010

    Report

    Report Number
    3003793371-2010-00039
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INFORMATION DID NOT INDICATE A POTENTIAL FOR INJURY. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE. ADDITIONAL F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE HELPDESK TO REPORT THAT THE IMRT PLANS ARE FAILING THE IMRT QA. THE SITE ALSO CLAIMS THAT NO CHANGES HAD BEEN MADE TO THE BEAM SETTINGS. OUR HELPDESK AGENT CONNECTED INTO THE SITE'S SYSTEM AND FOUND THAT THE BEAM ADD-ON PARAMETERS WERE CHANGED ON (B)(6) 2010 WHICH RESULTED IN THE MLC TRANSMISSION AND DOSIMETRIC LEAF GAP TO BE SET TO ZERO. ZERO IS THE DEFAULT PARAMETER. THIS WAS THE SOURCE OF THE QA DISCREPANCY AND THE CUSTOMER ALLEGES THAT NO WARNING WAS PRESENTED TO THE USER THAT THE BEAM SETTINGS HAD CHANGED. NO SERIOUS INJURY TO PT WAS REPORTED. NO PT DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM ACCELERATOR, LINEAR, MEDICAL MUJ VARIAN MEDICAL SYSTEMS H48-TPS

    Patients

    Seq Age Sex Outcome Treatment
    1