BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODYSSEY

    MDR report key: 1645676 · Received March 12, 2010

    Report

    Report Number
    2032139-2010-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 11, 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

    ADDITIONAL SERIAL NUMBERS: (B)(4). AN URGENT MEDICAL DEVICE CORRECTION LETTER WILL BE DISTRIBUTED TO ALL AFFECTED CUSTOMERS BY MARCH 18, 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 MAY 19, 2010 AT NO CHARGE. IN THE MEANTIME, THE FOLLOWING RECOMMENDATIONS ARE PROVIDED; ODYSSEY MACHINE LIBRARY ERROR, IT IS RECOMMENDED THAT THE CUSTOMER CONTACT PERMEDICS IF ANY MODIFICATIONS TO THE LIBRARY HAVE BEEN PERFORMED. THE PRIMARY VIEW SHOULD ALSO BE EXAMINED AND USED TO DETECT AND AVOID THE CONDITIONS CAUSING THE ANOMALY. FINALLY, INDEPENDENT FIELD SHAPE AND MONITOR UNIT CHECKS SHOULD BE PERFORMED AS PART OF A ROUTINE QUALITY ASSURANCE PROGRAM.

    Description of Event or Problem · 1

    ANOMALY, ODYSSEY MACHINE LIBRARY ERROR: THE ODYSSEY MACHINE LIBRARY CONTAINS CONFIGURATION INFORMATION FOR EACH TREATMENT MACHINE, MODE, ETC. CURRENTLY, IF THE MACHINE LIBRARY CONTAINS TREATMENT MODES WITH TWO DIFFERENT COLLIMATOR TYPES (FOR EXAMPLE, JAWS AND CONES), THEN IT IS POSSIBLE FOR THE SOFTWARE TO USE THE INCORRECT COLLIMATOR TYPE WHEN CALCULATING DOSE. IT WAS TESTED AND CONFIRMED THAT BASED ON OUR RECORDS OF THE CURRENT CUSTOMERS' LIBRARIES, THIS ANOMALY WILL NOT OCCUR. THIS ANOMALY CAN OCCUR ONLY IF THE USER MODIFIED THE COMMISSIONED MACHINE LIBRARY WITHOUT PERMEDICS' KNOWLEDGE SUCH THAT THE TREATMENT MODE THAT USES CIRCULAR CONES IS LISTED AS THE FIRST MODE USING JAWS AND THE MODE USING JAWS IS SELECTED DURING PLANNING. IN THIS CASE, THE SOFTWARE WOULD AUTOMATICALLY USE THE INCORRECT COLLIMATOR TYPE (CONE) WHEN CALCULATING DOSE.

    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