BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2029302 · Received February 18, 2011

    Report

    Report Number
    3003793371-2011-00003
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 27, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS BEING TREATED AT THE TIME. NO REPORTS OF SERIOUS DETERIORATION IN THE STATE OF HEALTH IS REPORTED. THE INFORMATION PROVIDED INDICATES THAT THIS ISSUE, SHOULD IT RECUR, MAY LEAD TO A MISADMINISTRATION OR SERIOUS INJURY. THOUGH IT HAS NOT YET BEEN DETERMINED WHICH PRODUCT (BRAINLAB VS. VARIAN) IS SUSPECT TO CREATING THE ANOMALY. INVESTIGATION OF THIS INCIDENT IS STILL IN PROCESS. DICOM DATA (REFERENCE CT IMAGES, STRUCTURE SET, PLAN AND DOSES) REQUESTED FROM CUSTOMER SITE. THE ISSUE IS BEING EVALUATED TO FURTHER MITIGATE THIS REPORTED INCIDENT. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN EXPORTING VIA DICOM RT SEPARATE BEAMS FROM BRAINLAB-IPLAN INTO VARIAN ARIA/ECLIPSE, PLANNED MONITOR UNITS (MU) WILL BE ALTERED IN ONE CASE BY 50MU IN ECLIPSE. THIS DOES NOT OCCUR WHEN EXPORTING PLANS THROUGH THE SAME PROCESS. THE CUSTOMER REPORTED THE OCCURRENCE TO BOTH BRAINLAB AND VARIAN. NO PATIENT WAS BEING TREATED AT THE TIME. NO REPORTS OF MISADMINISTRATION OR SERIOUS INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE SYS, PLANNING, RADIATION THERAPY TREATMENT MUJ VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS H48

    Patients

    Seq Age Sex Outcome Treatment
    1