BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1040800 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21401
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE LEFT MONITOR INTERMITTENTLY HAD BLACK LINE GOING ACROSS THE MIDDLE OF THE MONITOR. ALSO, THE SYSTEM HAD A WHITE IMAGE AND THEY HAD TO REBOOT. NO PT INJURIES WERE 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