BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMX-4

    MDR report key: 3249884 · Received March 12, 2013

    Report

    Report Number
    3249884
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 9, 2013
    Report Date
    March 12, 2013
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COLLIMATOR LOCK RELEASE INADVERTENTLY GOT STUCK AND AN ADDED WEIGHT (BOX OF GLOVES) ON TOP OF THE VERTICAL ARM CAUSED THE X-RAY/COLLIMATOR TO FALL DOWN TO THE PATIENT. ORDER COLLIMATOR & WEIGHT TO BALANCE THE TUBE/COLLIMATOR. PORTABLE TEMPORARILY TAKEN OUT OF SERVICE UNTIL REPLACEMENT PARTS & BALANCING OF X-RAY TUBE/COLLIMATOR WAS COMPLETED. COLLIMATOR WAS REPLACED AND ALIGNMENT CHECKED. WEIGHT WAS ADDED TO VERTICAL COLUMN TO BALANCE X-RAY TUBE/COLLIMATOR, BALANCE OF X-RAY TUBE/COLLIMATOR WAS CHECKED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?X-RAY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104982 AMX-4 SYSTEM, X-RAY, MOBILE OXO GE MEDICAL SYSTEMS, LLC 227 593 8-7 *
    104983 * * --- GE MEDICAL SYSTEMS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR