BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEG 9600

    MDR report key: 1699688 · Received July 10, 2009

    Report

    Report Number
    1720753-2009-05249
    Event Type
    Malfunction
    Date Received
    July 10, 2009
    Date of Event
    June 25, 2009
    Report Date
    July 10, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE HAS NOT YET EVALUATED THE SYSTEM. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WILL NOT FLUORO OR DISPLAY IMAGES. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1