BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 295707 · Received September 8, 2000

    Report

    Report Number
    2916556-2000-00335
    Event Type
    Malfunction
    Date Received
    September 8, 2000
    Date of Event
    August 9, 2000
    Report Date
    September 8, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT THE BLOCKS THAT WERE EXPORTED TO COMPUCUTTER WERE CUT WITH A 180 DEGREE ROTATION. THE USER WAS RUNNING 5.2G SOFTWARE WITH HUESTIS VERSION 2.4D COMPUCUTTER SOFTWARE. NO INJURIES HAVE BEEN 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 * HUESTIS COMPUCUTTER.