BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE

    MDR report key: 1996028 · Received January 24, 2011

    Report

    Report Number
    1525965-2011-00003
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Report Date
    December 27, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CAUSE OF THE ISSUE WAS IDENTIFIED TO BE A SINGLE CONTOUR KEPT IN THE EDIT MODE AND THE SOFTWARE DOES NOT FORCE THE USER TO EXIT THE EDIT MODE BEFORE SAVING. WHEN SAVING IN THIS MANNER, THE SOFTWARE INCORRECTLY SHIFTS TO THE LOCATION(S) OF THE LAST CONTOUR IN THE LAST REGION OF INTEREST DEFINED IN THE ORGAN LIST. THE SOFTWARE WAS CORRECTED AND IMPLEMENTED TO ENSURE THAT THE CONTOUR EDITING MODE IS CLOSED BEFORE EXITING. THIS REPORT WAS SUBMITTED ON (B)(4) 2011.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT THAT ALLEGED THAT AS PART OF THE USER'S STANDARD CT SIMULATION PROCESS FOR TREATMENT OF BREAST LESIONS, THE USER IS ABLE TO DRAW A SINGLE SLICE STRUCTURE. HOWEVER, WHEN THE USER SAVES THE CONTOUR IN EDIT MODE, IT SHIFTS TO THE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE BIG BORE JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1