BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC ITRAK 3500P

    MDR report key: 1021010 · Received March 28, 2008

    Report

    Report Number
    1225258-2008-00009
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    August 18, 2004
    Report Date
    March 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RESEATED THE MOUSE CABLE. SYSTEM OPERATES AS INTENDED. THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED IS 9. PLEASE NOTE THE MDRS ASSOCIATED WITH THIS REPORT ARE FILED LATE IN RESPONSE TO THE REMEDIATION EFFORTS OF GE HEALTHCARE. THIS REPORT IS FILED UNDER THE FDA'S RETROSPECTIVE SUMMARY REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM SHUT DOWN DURING A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC ITRAK 3500P FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. IT3500P NA

    Patients

    Seq Age Sex Outcome Treatment
    1