BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1441107 · Received August 18, 2009

    Report

    Report Number
    1720753-2009-03163
    Event Type
    Malfunction
    Date Received
    August 18, 2009
    Date of Event
    March 25, 2009
    Report Date
    April 20, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE INTERCONNECT CABLE. SYSTEM OPERATES AS INTENDED. (B) (4) 06/18/2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1