BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 606498 · Received May 18, 2005

    Report

    Report Number
    2914292-2005-00005
    Event Type
    Malfunction
    Date Received
    May 18, 2005
    Date of Event
    May 6, 2005
    Report Date
    May 17, 2005
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A DRR DID NOT GET RECALCULATED FOLLOWING A COPY AND PASTE OPERATION OF A FIELD WITH A DRR. NO MISTREATMENT OCCURRED AND NO PT WAS INVOLVED. THIS IS BEING REPORTED BECAUSE CO CANNOT RULE OUT THAT THIS CONDITION WILL LIKELY LEAD TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM IYE VARIAN MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other