BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM MG EAGLE GANTRY

    MDR report key: 720318 · Received July 28, 2005

    Report

    Report Number
    9613299-2005-00003
    Event Type
    Malfunction
    Date Received
    July 28, 2005
    Date of Event
    July 1, 2005
    Report Date
    July 28, 2005
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED HEARING UNUSUAL NOISES IN THE MILLENIUM MG EAGLE GANTRY DURING A PATIENT SCAN; THEN SUBSEQUENTLY OBSERVING A RADIAL ERROR MESSAGE. A SERVICE REPRESENTATIVE WAS CALLED. DURING THE SERVICE CALL, THE SERVICE ENGINEER REPORTED A DISENGAGEMENT OF A DETECTOR HEAD IN MG SYSTEM THAT RESULTED IN UNCONTROLLED MOTION IN RADIAL DIRECTION. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM MG EAGLE GANTRY NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS F.I. HAIFA 2184116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO