BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1852062 · Received September 28, 2010

    Report

    Report Number
    1720753-2010-03236
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    May 20, 2010
    Report Date
    September 28, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MONITOR WAS REPLACED DURING THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6800 SYSTEM HAD A MONITOR ISSUE. THE REPORT STATED LED CAN NOT LIGHT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1