BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 532334 · Received March 9, 2004

    Report

    Report Number
    2916556-2004-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2004
    Date of Event
    February 12, 2004
    Report Date
    February 24, 2004
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ONE USER SITE REPORTED DISCOVERING A SOFTWARE MALFUNCTION ON PINNACLE3 VERSION 7.0E THAT IS RELATED TO THE MOTORIZED WEDGE FUNCTIONALITY WHEN USING AN ELEKTA LINEAR ACCELERATOR. 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 SOFTWARE IYE ADAC LABORATORIES 9200-9052A-ENG SOFTWARE VER.7.0E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN