BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600EMI

    MDR report key: 1031036 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20667
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POOR IMAGE QUALITY ON PAIN MGMT USING A 9600 9" II WITH A STERIS AMSCO SURGICAL TABLE. THE SYS PASSES ALL RESOLUTION TESTS. PROBLEM MAY BE CAUSED BY THE SURGICAL TABLE AND PADDING. NO PT HARMED. CUSTOMER COMPLETED CASE WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600EMI FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1