BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2601087 · Received May 24, 2012

    Report

    Report Number
    3003793371-2012-00006
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGEST A MALFUNCTION IN THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCORRECT MU WHEN RE-CALCULATING A RAPID ARC PLAN WITH NEW PRESCRIPTION. ACCORDING TO THE REPORT, THERE WAS NO PT ASSOCIATED WITH THIS EVENT. NO PT INJURY HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1