BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODYSSEY

    MDR report key: 1915413 · Received November 4, 2010

    Report

    Report Number
    2032139-2010-00004
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PERMEDICS, INC.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN URGENT MEDICAL DEVICE CORRECTION LETTER WILL BE DISTRIBUTED TO ALL AFFECTED CUSTOMERS BY (B)(6) 2010, WITH A DESCRIPTION OF THE ANOMALY AND USER CORRECTIVE ACTION STEPS. THE LETTER WILL ALSO BE DISTRIBUTED TO THE PERMEDICS SALES ORGANIZATIONS, INFORMING THEM OF THE ISSUE. A MANDATORY UPGRADE WILL BE PROVIDED BY (B)(6) 2011 AT NO CHARGE. IN THE MEANTIME, THE FOLLOWING RECOMMENDATIONS ARE PROVIDED: IF, PRIOR TO THE SOFTWARE CORRECTION, ANY OF THESE AFFECTED FILETYPES WERE EXPORTED FROM ODYSSEY, MANUALLY VERIFY THAT THE TABLE AND COLLIMATOR ANGLES ARE CORRECT. ADDITIONALLY, APPLY APPROPRIATE CHANGES TO ANY ANGLES DEEMED INCORRECT THAT WERE OBTAINED FROM ODYSSEY'S DICOM RT ION PLAN, DICOM RT IMAGE, AND/OR RTP LINK FILES. NOTE: THE FOLLOWING MUST ALL BE PRESENT IN ORDER FOR AN INVALID TABLE AND/OR COLLIMATOR ANGLE TO BE EXPORTED FOR A BEAM: THE INTERNAL TABLE AND/OR COLLIMATOR ANGLE OF THE BEAM DISPLAYED IN ODYSSEY IS NOT EQUAL TO ZERO. THE TABLE AND/OR COLLIMATOR ANGLE SYSTEM FOR THE BEAM'S MACHINE IS DEFINED IN ODYSSEY'S MAKELIB TO INCREASE IN THE CLOCKWISE DIRECTION WHEN VIEWED IN ODYSSEY'S "BEAM'S EYE VIEW" FEATURE. THE BEAM IS EXPORTED TO A DICOM RT ION PLAN, DICOM RT IMAGE, OR RTP LINK FILE.

    Description of Event or Problem · 1

    DURING PERMEDICS' INTERNAL CODE REVIEWS FOR (B)(4) COMPLIANCE VERIFICATION, AN ISSUE WAS IDENTIFIED BY PERMEDICS ENGINEERS: ODYSSEY DOES NOT EXPORT THE CORRECT TABLE AND/OR COLLIMATOR ANGLES TO DICOM RT ION PLAN, DICOM RT IMAGE AND RTP LINK WHEN THE TREATMENT MACHINE'S TABLE ANGLE AND/OR COLLIMATOR ANGLE INCREASE IN THE CLOCKWISE DIRECTION--OPPOSITE OF THE (B)(4) AND ODYSSEY'S INTERNAL ANGLE SYSTEMS. IN THESE CASES, ODYSSEY CONVERTS THE TABLE AND COLLIMATOR ANGLES TO THE TREATMENT MACHINE'S ANGLE SYSTEM, WHICH DOES NOT MATCH (B)(4). THIS CONVERSION SHOULD NEVER BE PERFORMED FOR THESE FILES. BECAUSE ODYSSEY'S DICOM AND RTP LINK EXPORTS ARE SUPPOSED TO EXPRESS ANGLES IN (B)(4) COORDINATES, THIS CONVERSION RESULTS IN INCORRECT TABLE AND COLLIMATOR ANGLE VALUES WHEN THE TABLE AND COLLIMATOR ANGLE SYSTEMS OF THE BEAM'S MACHINE DO NOT MATCH ODYSSEY'S INTERNAL ANGLE SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODYSSEY RADIATION TREATMENT PLANNING SYSTEM MUJ PERMEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1