BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1140693 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24307
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP PERFORMED A SYSTEM FILAMENT CALIBRATION USING UTILITY SUITE, SAVED TO SYSTEM AND PERFORMED OPERATIONAL CHECKS TO INCLUDE IMAGE QUALITY TEST AS OUTLINED IN MAINTENANCE PROCEDURE. NO PROBLEMS NOTED, SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORT INDICATES A LOW MA ERROR ON C-ARM DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND NO AFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1