BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1232567 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-27995
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 12, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP COULD NOT DUPLICATE THE PROBLEM. HE REPLACED THE COLLIMATOR AND TRANSFERRED A SECONDARY COLLIMATOR FILTER FROM THE OLD COLLIMATOR TO NEW COLLIMATOR. HE PERFORMED A BEAM ALIGNMENT AND COLLIMATOR CALIBRATION. HE VERIFIED COLLIMATOR FUNCTION AND VERIFIED A SYSTEM BOOT AND FLUORO FUNCTION. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A COLLIMATOR IRIS TOO LARGE ERROR MESSAGE DISPLAYED ON THE SYSTEM. NO PATIENT INJURY WAS REPORTED.

    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