BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 291503 · Received August 18, 2000

    Report

    Report Number
    2916556-2000-00320
    Event Type
    Malfunction
    Date Received
    August 18, 2000
    Date of Event
    June 27, 2000
    Report Date
    August 16, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT THE CUSTOMER REPORTED THE "SSD'S" IN THE PLAN CHANGED. THE CUSTOMER HAD RUN THE PLAN EARLIER AND WENT INTO THE PLAN TO EDIT THE PRESCRIPTION. THEY NOTICED AFTER THEY HAD EDITED THE PRESCRIPTION THAT THE "SSD'S" FOR THE 2 BEAMS WERE IDENTICAL (90.14). ON THE PRINTOUT, THE "SSD'S" UNDER GEOMETRY WAS LISTED AS 90.14 FOR EACH BEAM, BUT THE "SSD'S" TO REFERENCE POINT WERE REPORTED CORRECTLY. 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 *