BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE

    MDR report key: 2121909 · Received May 23, 2011

    Report

    Report Number
    1525965-2011-00027
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Report Date
    March 4, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS DETERMINED THAT THIS IS A SIGNIFICANT WORKFLOW RELATED ISSUE AS OPPOSE BEAM DOES NOT WORK THE SAME WAY AS COPY AND OPPOSE BEAM AND DOES NOT WORK IN THE MANNER IN WHICH THE USER WOULD EXPECT. THIS SITUATION MAY RESULT IN PT HARM IF THE DOCTOR DOES NOT DOUBLE-CHECK THE BEAM SETUP PRIOR TO TREATMENT. THE ROOT CAUSE WAS IDENTIFIED AS A CODE DEFECT RESULTING FROM THE SOFTWARE NOT CHECKING FOR INVALID INPUT WHEN USING THE OPPOSE FUNCTION DURING BEAM PLANNING. IT IS A STANDARD PRACTICE FOR A DOCTOR TO DOUBLE-CHECK EACH BEAM'S SETUP PRIOR TO TREATMENT WHICH WOULD PREVENT ANY HARM TO THE PT.

    Description of Event or Problem · 1

    (B)(6) REPORTED AN UNEXPECTED SYSTEM BEHAVIOR RELATED TO TUMORLOC APPLICATION ON BRILLIANCE BIGBORE CT SCANNER. WHEN USING TUMORLOC FOR TREATMENT PLANNING, IF A NEW BEAM CONTAINING A BLOCK IS CREATED USING COPY AND OPPOSE OPERATION ON AN EXISTING BEAM CONTAINING BLOCK, THE BLOCK SETTINGS ARE NOT PROPERLY PROPAGATED. THE OPPOSE BEAM ON THE BEAM GEOMETRY PANEL JUST OPPOSES THE BEAM BUT DOES NOT COPY OVER ANY BLOCKS ASSOCIATED WITH THE BEAM TO THE OPPOSED BEAM. NO HARM TO THE PTS HAVE BEEN REPORTED BY (B)(6).

    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 NA