BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1083721 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-24039
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CAMERA WAS FOCUSED AND THE BATTERIES REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED, AND FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM POOR IMAGE QUALITY DURING A CASE WITH A LARGE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1