BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1933134 · Received December 13, 2010

    Report

    Report Number
    3003793371-2010-00038
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED BEHAVIOR IS RARE, SPORADIC AND NOT REPRODUCIBLE ON CUSTOMER SITE. ATTEMPTS TO REPRODUCE THE ALLEGATION HAVE THUS FAR FAILED DUE TO THE UNAVAILABLE LOG FILES. ATTEMPTS TO REPRODUCE THE ALLEGATION HAVE BEEN UNSUCCESSFUL. NO MISADMINISTRATION OCCURRED IN THIS CASE. HOWEVER, THIS TYPE OF COMPLAINT WILL BE MONITORED FOR RECURRENCE. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MLC UPDATE DOES NOT INVALIDATE DOSE. NO PT INJURY REPORTED, AND NO PT DATA PROVIDED.

    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