BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    MDR report key: 900919 · Received August 21, 2007

    Report

    Report Number
    3004022368-2007-00001
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Date of Event
    July 30, 2007
    Report Date
    August 21, 2007
    Manufacturer
    PHILIPS NUCLEAR MEDICINE, INC
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AN INTERNAL EVALUATION CONFIRMS THAT PINNACLE3 RADIATION THERAPY PLANNING SYSTEM SOFTWARE VERSIONS 7.6C, 8.0D AND 8.0H EXHIBIT A SOFTWARE DEFECT WITH THE ABSOLUTE PT MARKING FEATURE OF THE ACQSIM3 SIMULATION APPLICATION WHEN USED IN COMBINATION WITH THE PHILIPS/PICKER PQ-SERIES CT SCANNER.

    Description of Event or Problem · 1

    PRODUCT PROBLEM. ONE USER SITE REPORTED DISCOVERING A SOFTWARE MALFUNCTION WHEN USING THE PHILIPS PINNACLE3 RADIATION THERAPY PLANNING SYSTEM SOFTWARE VERSION 8.0H ABSOLUTE MARKING FEATURE OF THE ACQSIM3 SIMULATION APPLICATION IN COMBINATION WITH A PHILIPS/PICKER PQ 2000S CT SCANNER. THE SOFTWARE MALFUNCTION COULD RESULT IN INCORRECT PT MARKING, WHICH COULD POTENTIALLY LEAD TO IMPROPER PT TREATMENT. NO PT INJURY, MISDIAGNOSIS OR MISTREATMENT RESULTED FROM THIS EVENT.

    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 9200-0700C-ENG SOFTWARE VER. 8.0H

    Patients

    Seq Age Sex Outcome Treatment
    1 YR PHILIPS VOXE1Q WORKSTATION| PHILIPS/PICKER PQ2000S CT SCANNER