BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 299028 · Received September 28, 2000

    Report

    Report Number
    2916556-2000-00344
    Event Type
    Malfunction
    Date Received
    September 28, 2000
    Date of Event
    August 29, 2000
    Report Date
    September 28, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT THE LASER LOCALIZATION INFO WILL BE INCORRECT IF THE PT IS TREATED IN A DIFFERENT POSITION THAN THAT IN WHICH THEY WERE SCANNED. IF THE USER SCANS THEIR PT'S FEET FIRST, BUT TREATS THEM HEAD FIRST, THE LASER SHIFT INFO WILL BE BACKWARDS FOR THE LASER LEFT/RIGHT AS WELL AS THE TABLE IN/OUT POSITIONS. THIS PROBLEM CAN LEAD TO THE INCORRECT ISOCENTER BEING MARKED ON THE PT. THERE HAVE BEEN NO REPORTS OF INJURY 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 *