BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1085790 · Received August 4, 2008

    Report

    Report Number
    1720753-2008-23579
    Event Type
    Malfunction
    Date Received
    August 4, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 16, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP CONDUCTED AN ON SITE EVALUATION. THE PROBLEM WAS VERIFIED. THE REP REPLACED THE ASM,PCB,CONT PNL ON THE WORKSTATION. SYSTEM NOW OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM PRODUCED A KEYBOARD ERROR DURING A CASE. SYSTEM HAD OT BE RE-BOOTED TO CLEAR ERROR AND COMPLETE CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. GE OEC 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1