BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECLIPSE

    MDR report key: 472206 · Received July 11, 2003

    Report

    Report Number
    2914292-2003-00004
    Event Type
    Other
    Date Received
    July 11, 2003
    Report Date
    July 10, 2003
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A COMPUTER SYSTEM CRASH OCCURRED IN A HOSP. SUBSEQUENT TO THE CRASH, A CORRUPTED FILE WAS USED IN CALCULATING FIELDS HAVING ENHANCED DYNAMIC WEDGE RESULTING IN UNEXPECTED DOSE DISTRIBUTION. IT HAS BEEN REPORTED THAT MISTREATMENTS HAVE OCCURRED, HOWEVER THE EXTENT HAS NOT BEEN DETERMINED. THIS MDR IS FILED BECAUSE SERIOUS INJURY CANNOT BE RULED OUT AS THIS TIME. THIS EVENT WAS REPORTED IN JUNE 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS VERSION 6.5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other