BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1040740 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21358
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP PERFORMED A COLLIMATOR CALIBRATION. AS A PRECAUTIONARY MEASURE FLASHED NODES AND RE-LOADED CAL FILES. SYSTEM BOOTED 5 TIMES ERROR WITH NO DUPLICATION OF ERROR DISPLAYED ON CONTROL PANEL. THE SERVICE REP OPENED/CLOSED COLLIMATOR IRIS. MOVEMENT AND ICON OPERATING AS INTENDED. HE VERIFIED COLLIMATOR LEAVES, ICONS NOW PRESENT WHEN OPENED/CLOSED, OPERATING AS INTENDED. TIGHTENED LOOSE HANDLE ON C-ARM. OVERALL SYSTEM FUNCTIONAL CHECKED AND FOUND OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE COLLIMATOR IS STUCK. VERIFIED CUSTOMER'S REPORT. ALSO NOTED IRIS TOO LARGE ERROR ON CONTROL PENAL. COLLIMATOR LEAVES OPERATIONAL BUT NO ICON DISPLAYED WHEN CLOSED, OPENED, OR ROTATED. INSPECTED CONNECTIONS. NO DEFECTS FOUND. SYSTEM REQUIRES COLLIMATOR CALIBRATION.

    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