BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 299033 · Received September 28, 2000

    Report

    Report Number
    2916556-2000-00345
    Event Type
    Malfunction
    Date Received
    September 28, 2000
    Date of Event
    August 30, 2000
    Report Date
    September 28, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT THE POI'S IN AN IMPORTED OLDELFT DATASET RESET TO ZERO Z POSITION. THIS COULD RESULT IN INCORRECT BEAM PLACEMENT DURING PLANNING. NO INJURIES WERE 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 * OLDELFT IMAGE DATA.