BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1014245 · Received March 12, 2008

    Report

    Report Number
    9680959-2008-00042
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MONITOR HAS POOR IMAGE A'S AND Y'S. THE PROBLEM BEGAN BEFORE A CASE. NO PATIENT INVOLVEMENT, PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1