BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 229069 · Received June 23, 1999

    Report

    Report Number
    2916556-1999-00021
    Event Type
    Malfunction
    Date Received
    June 23, 1999
    Date of Event
    March 12, 1998
    Report Date
    June 22, 1999
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PRINTED REPORTS OF "POI" DOSE WITH MORE THAN TWENTY BEAMS CAN RUN OFF THE PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE3 RADIATION THERAPY PLANNING EQUIPMENT IYE ADAC LABORATORIES 9200-2126B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *