BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    MDR report key: 1172704 · Received September 13, 2008

    Report

    Report Number
    3004022368-2008-00001
    Event Type
    Other
    Date Received
    September 13, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 10, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AN INTERNAL EVAL CONFIRMS THAT THIS USER FACILITY USED A PLAN CREATED WITH THE INCORRECT POI (POINT OF INTEREST) AS THE ISOCENTER AND USED IT FOR TREATMENT. USER DOCUMENTATION PROVIDES INSTRUCTION RELATIVE TO THE CREATION OF POIS AND THE APPROPRIATE QUALITY ASSURANCE CHECKS TO PREVENT THIS ERROR. NO PRODUCT MALFUNCTION HAS OCCURRED. NO KNOWN PT INJURY HAS OCCURRED. THE PINNACLE RADIATION THERAPY PLANNING SYSTEM PRODUCT ONLY ALLOWS THE USER TO DEVELOP RADIATION TREATMENT PLANS AND IS NOT A RADIATION THERAPY TREATMENT DEVICE ITSELF. THE PINNACLE PRODUCT PERFORMED AS INTENDED. THERE WERE NO PRODUCT MALFUNCTION ASSOCIATED WITH THE REPORTED EVENTS.

    Description of Event or Problem · 1

    WHILE PHILLIPS APPLICATION SUPPORT WAS WORKING WITH THE USER FACILITY, IT WAS DETERMINED THAT THE INCORRECT ISOCENTER WAS USED IN A PT TREATMENT. THE USE OF THIS INCORRECT ISOCENTER CAUSED THE DOSE TO BE DELIVERED TO THE INCORRECT LOCATION. THE USER FACILITY CONSIDERS THIS TO BE A 20% DOSE ERROR. ONE FRACTION OF TREATMENT HAD TAKEN PLACE PRIOR TO DISCOVERING THE INCORRECT ISO CENTER. 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 MEDICAL SYSTEMS (CLEVELAND), INC 453560461331 SOFTWARE VER 8.0M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other