BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL ELECTRIC

    MDR report key: 707138 · Received April 26, 2006

    Report

    Report Number
    707138
    Event Type
    Injury
    Date Received
    April 26, 2006
    Date of Event
    April 8, 2006
    Report Date
    April 20, 2006
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS PLACED IN LAB#1 FOR A CARDIAC CATHETERIZATION. AN EQUIPMENT FAILED DURING THE PROCEDURE AND THE PT WAS TRANSFERRED TO LAB#2 TO BE COMPLETED DUE TO EQUIPMENT MALFUNCTION. NO ADVERSE OUTCOME TO PT, DISCHARGED IN 2006 WITH INSTRUCTIONS AND PRESCRIPTION. GE WAS NOTIFIED OF THE INCIDENT AND THE EQUIPMENT WAS FIXED AND IS WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC INNOVA #2000 UNIT CARDIAC CATH DXG GENERAL ELECTRIC 22245590 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention