BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1021741 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19716
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SVC REP REPLACED MONITORS AND LIGHT SENSOR. HE PERFORMED A MONITOR AND LIGHT SENSOR CALIBRATION. TESTED, SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    AS THE SVC REP WAS REPLACING PARTS ON A SYSTEM, HE FOUND THE MONITORS TO BE BURNED OUT. THE SVC REP REPLACED THE MONITOR. NO PT WAS INVOLVED.

    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