BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA NX

    MDR report key: 646011 · Received November 11, 2005

    Report

    Report Number
    2126677-2005-00032
    Event Type
    Injury
    Date Received
    November 11, 2005
    Date of Event
    October 5, 2005
    Report Date
    November 11, 2005
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN SETTING UP A OPTIMA NX SYSTEM FOR A TOMOGRAPHIC SCAN, THE OPERATOR ROTATED THE GANTRY TO THE TOMO START POSITION RESULTING IN THE DETECTOR HEAD COLLIDING WITH THE PT ARM. THE PT SUFFERED A BROKEN ARM. A STATIC SCAN OF THE PT USING THE SAME SYSTEM HAD JUST BEEN COMPLETED PRIOR TO THIS INCIDENT. THE OPERATOR ACKNOWLEDGED A USER INTERFACE PROMPT TO AUTOMATICALLY MOVE THE CAMERA FROM THE STATIC SCAN TO THE TOMO START POSITION. THE PT WAS NOT APPROPRIATELY POSITIONED FOR THE COMMANDED MOTION. THE PT'S ARM WAS CAUGHT BETWEEN A STRETCHER AND ONE OF THE CAMERA'S DETECTOR HEADS WHEN THE CAMERA REPOSITIONED. ALTHOUGH THE SYSTEM USES A CLUTCH MECHANISM TO MINIMIZE THE FORCE APPLIED BY THE DETECTOR IN THE EVENT OF COLLISION, THIS INJURY STILL OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA NX NUCLEAR MEDICINE IYY GE MEDICAL SYSTEMS, LLC 9SYS0088-D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention