BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE

    MDR report key: 373468 · Received January 16, 2002

    Report

    Report Number
    2916556-2002-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2002
    Date of Event
    December 13, 2001
    Report Date
    January 15, 2002
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Removal / Correction Number
    006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT A COLLIMATOR FELL OFF THE DETECTOR ONTO THE FLOOR. THE COLLIMATOR FELL WHEN GANTRY ROTATE WAS INITIATED, SUBSEQUENT TO A COLLIMATOR EXCHANGE PROCEDURE. NO INJURY WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2155-3004B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *