BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA IV COMPACT X-RAY TABLE

    MDR report key: 6041018 · Received October 19, 2016

    Report

    Report Number
    6041018
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 13, 2016
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MORBIDLY OBESE PATIENT WAS HAVING A FIBRILLATION OR PULMONARY VEIN ISOLATION PROCEDURE IN EP LAB. THE X-RAY TABLE IS FROM GENERAL ELECTRIC MEDICAL SYSTEMS WITH SYSTEM ID INNOVA. THE DOCTOR HAD DIFFICULTY EXCHANGING THE SHEATH IN THE RIGHT GROIN AND MOVED THE TABLE FORWARD TO LOOK AT THE GROIN UNDER FLUORO. WHEN THE TABLE WAS MOVED, THERE WAS A LOUD NOISE AND THE UPPER PART OF THE TABLE DROPPED AND THE BASE OF THE TABLE LIFTED UP FROM THE FLOOR. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO A STRETCHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693242 OMEGA IV COMPACT X-RAY TABLE SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB GE HEALTHCARE, LLC 2320221-3

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR OTHER DEVICES WERE USED ON THE PATIENT AT THIS TIM