BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM MPR GANTRY

    MDR report key: 495873 · Received November 12, 2003

    Report

    Report Number
    9613299-2003-00006
    Event Type
    Malfunction
    Date Received
    November 12, 2003
    Date of Event
    October 23, 2003
    Report Date
    November 12, 2003
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PIN HOLDING THE PITCH DRIVE ASSEMBLY TO THE COUNTER WEIGHT HAS A CLIP ON EITHER END TO KEEP IT IN PLACE. ONE OF THESE CLIPS CAME OFF, FOR UNK REASONS, AND THE PIN FELL OUT. THE DETECTOR FELL AND HIT THE TABLE BASE. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM MPR GANTRY NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING ASM000126 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA