BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KODAK DIGITAL U ARM

    MDR report key: 625258 · Received July 5, 2005

    Report

    Report Number
    625258
    Event Type
    Malfunction
    Date Received
    July 5, 2005
    Date of Event
    June 6, 2005
    Report Date
    July 5, 2005
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BUCKY LOCK IN ER FAILED TO LOCK IN POSITION. WHEN THE TECH MOVED IT FOR A RADIOLOGY PROCEDURE, ARM ROTATED FLAT AND WAS CAUGHT BY THE TECH, BUT IT STRUCK THE PATIENT IN THE SHOULDER AND FRIGHTENED THE PATIENT. THE PATIENT WAS CRYING, BUT THERE WAS NO APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIGITAL U ARM BUCKY LOCK OF KODAK DIGITAL U ARM JAA EASTMAN KODAK COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR