BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW DR 9000 SYSTEM

    MDR report key: 645148 · Received November 3, 2005

    Report

    Report Number
    1317307-2005-00006
    Event Type
    Other
    Date Received
    November 3, 2005
    Date of Event
    October 28, 2005
    Report Date
    November 2, 2005
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WITH A BACK INJURY WAS HIT BY A KODAK DIRECTVIEW DR 9000 BUCKY WHILE BEING POSITIONED FOR AN X-RAY IMAGE. THE PT WAS SITTING UPRIGHT ON A MOVEABLE RADIOGRAPHIC TABLE AND THE KODAK DIRECTVIEW DR9000 SYSTEM BUCKY (DETECTOR) WAS BEING POSITIONED BEHIND THE PT FOR AN X-RAY IMAGE OF HER SPINE WHEN THE BUCKY TILT BUTTON ON THE BOTTOM OF THE BUCKY BECAME DEPRESSED AND RELEASED THE BRAKE LOCK. WHEN THE BRAKE LOCK WAS RELEASED THE BUCKY TILTED INTO THE PT'S BACK. AFTER THE BUCKY HIT THE PT'S BACK. THE PT COMPLAINED THAT THERE WAS NO FEELING IN HER LEGS. ACCORDING TO THE HOSPITAL, HOWEVER, THIS WAS A TEMPORARY CONDITION AND THERE WAS NO PERMANENT INJURY CAUSED BY THIS EVENT. KODAK WAS NOT ABLE TO CONFIRM WITH THE USER IF MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW DR 9000 SYSTEM DIAGNOSTIC X-RAY SYSTEM MQB EASTMAN KODAK COMPANY DR 9000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other