BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    MDR report key: 911746 · Received September 12, 2007

    Report

    Report Number
    3004022368-2007-00002
    Event Type
    Other
    Date Received
    September 12, 2007
    Date of Event
    August 8, 2007
    Report Date
    September 12, 2007
    Manufacturer
    PHILIPS NUCLEAR MEDICINE, INC.
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AN INTERNAL EVALUATION CONFIRMS THAT THE USER FACILITY HAS BEEN USING INCORRECT CALIBRATION VALUES TO GENERATE RADIATION TREATMENT PLANS. NO PRODUCT MALFUNCTION HAS OCCURRED. NO KNOWN PATIENT INJURY HAS OCCURRED. THE PINNACLE3 RADIATION THERAPY PLANNING SYSTEM PRODUCT ONLY ALLOWS THE USER TO DEVELOP A RADIATION TREATMENT PLAN AND IS NOT A RADIATION THERAPY TREATMENT DEVICE ITSELF. THE PINNACLE3 PRODUCT PERFORMED AS INTENDED. THERE WERE NO PRODUCT MALFUNCTIONS ASSOCIATED WITH THE REPORTED EVENTS.

    Description of Event or Problem · 1

    WHILE WORKING WITH ONE USER FACILITY ON A CUSTOMER SUPPORT PHONE CALL, THE PHILIPS MEDICAL SYSTEMS CUSTOMER SUPPORT GROUP DISCOVERED THAT THE USER FACILITY MAY HAVE BEEN USING INCORRECT CALIBRATION VALUES WITH THE PHILIPS PINNACLE3 RADIATION THERAPY PLANNING SYSTEM SOFTWARE VERSION 6.2B PRODUCT FOR THE LAST SEVERAL YEARS. INFORMATION SUGGESTS THAT INCORRECT CALIBRATION VALUES ON THE ORDER OF 6.5% MAY HAVE BEEN USED. THE INCORRECT CALIBRATION VALVES COULD LEAD TO SYSTEMATICALLY LOW MONITOR UNITS, THUS RESULTING IN A LOWER RADIATION DOSE BEING PLANNED FOR A PT. THE RADIATION DOSE DISCREPANCY COULD RESULT IN AS MUCH AS A 7.1% UNDERDOSE IF NOT CAUGHT BY STANDARD CLINICAL QUALITY ASSURANCE PRACTICES. NO PRODUCT MALFUNCTION HAS BEEN ALLEGED. NO KNOWN PT INJURY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM SYSTEM, PLANNING, RADIATION THERAPY MUJ PHILIPS NUCLEAR MEDICINE, INC. 9200-0613A-ENG SOFTWARE VER. 6.2B

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other