BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KODAK DIRECTVIEW CR 800 SYSTEM

    MDR report key: 441718 · Received February 6, 2003

    Report

    Report Number
    1317307-2003-00001
    Event Type
    Injury
    Date Received
    February 6, 2003
    Date of Event
    January 7, 2003
    Report Date
    February 6, 2003
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CR 800 IMAGE WAS OBTAINED ON A PT PRIOR TO HIP REPLACEMENT SURGERY. CLINICAL INTERPRETATION OF THE IMAGE TO OBTAIN MEASUREMENTS OF SELECT PROSTHESIS WAS PERFORMED ON AN EFILM WORKSTATION. THE EFILM DEVICE, MANUFACTURED BY MERGE EFILM, HAS SOFTWARE VERSION 1.8.3 INSTALLED AND THE KODAK DIRECTVIEW CR 800 WAS RUNNING VERSION 2.2.1. THE CUSTOMER REPORTED AN ESTIMATED 10% INACCURACY IN THE MEASUREMENTS RESULTING IN INCORRECT FIT OF THE HIP PROSTHESIS. ADDITIONAL SURGERY WAS REQUIRED TO CORRECT THE PROBLEM. THE INCIDENT WAS REPORTED BY HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW CR 800 SYSTEM ELECTROSTATIC X-RAY IMAGING SYSTEM MQB EASTMAN KODAK COMPANY CR 800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other EFILM WORKSTATION MANUFACTURED BY MERGE EFILM,| MILWAUKEE, WI.