BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 304863 · Received November 10, 2000

    Report

    Report Number
    2916556-2000-00367
    Event Type
    Malfunction
    Date Received
    November 10, 2000
    Date of Event
    October 12, 2000
    Report Date
    November 9, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT THE DOSE IS INCORRECTLY INVALIDATED IN THE SMARTSIM APPLICATION. THE USER OBSERVED THAT THE SELECTED BEAM WAS THE "RPO BOOST" WHILE THE BEAM DISPLAYED IN THE DRR WAS THE "LAO BOOST." ALL BEAMS WERE COMPUTED EXCEPT THE LAO BOOST. AFTER ADDING A BLOCK TO THE LAO BOOST THEY NOTED THAT THE DOSE WAS INVALIDATED FOR THE RPO BEAM, NOT THE LAO BOOST BEAM. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE3 RADIATION THERAPY PLANNING EQUIPMENT IYE ADAC LABORATORIES 9200-0579A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *