BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1133697 · Received August 20, 2008

    Report

    Report Number
    1720753-2008-24882
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 20, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP ORDERED A NEW MONITOR AND REPLACED THE DEFECTIVE MONITOR. HE SETUP BRIGHTNESS AND CONTRAST ACCORDING TO IMAGE QUALITY HANDBOOK USING RUS. HE CHECKED AND ASSURED THAT THE UNIT WAS OPERATING ACCORDING TO MANUFACTURER'S SPEC, UNIT WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR DOES NOT COME ON. 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