BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLINNIUM MG COLLIMATOR

    MDR report key: 679621 · Received February 21, 2006

    Report

    Report Number
    9613299-2006-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2006
    Date of Event
    January 23, 2006
    Report Date
    February 21, 2006
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PRE-PROCEDURE PREPARATION, THE USER NOTICED THAT THE MILLENIUM MG COLLIMATOR HAD PARTIALLY RELEASED FROM TWO OF ITS FOUR LOCKING MECHANISMS. THERE WAS NO REPORT OF THE COLLIMATOR FALLING. A PATIENT WAS NOT INVOLVED AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLINNIUM MG COLLIMATOR NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS F.I. HAIFA 2181002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA