BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC MECHANICS

    MDR report key: 538556 · Received March 23, 2004

    Report

    Report Number
    9611343-2004-00008
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 23, 2004
    Manufacturer
    GEMS EUROPE
    Product Code
    IZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ROTATED C-ARM LAO WITH THE TABLE MOUNTED LEAD SHIELD IN THE PATH. THE SUPPORT BAR FOR THE SHIELD SNAGGED THE OIL LINE, AND PULLED IT OFF OF THE TUBE. OIL WAS PUMPED INTO THE ROOM, AND ONTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC MECHANICS DIAGNOSTIC X-RAY IZI GEMS EUROPE 45562281 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention