BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2193178 · Received July 21, 2011

    Report

    Report Number
    1720753-2011-20275
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE MONITOR WAS READJUSTED WITHOUT SUCCESS. THE LEFT MONITOR NEEDS TO BE REPLACED TO MAINTAIN IMAGE CONSTANCY. THE SYSTEM WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A DEGRADED GRAY VALUES IMAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1