BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OE 9800

    MDR report key: 1040842 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21369
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE HAND AND FOOT SWITCHES WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM HAD AN X-RAY SWITCH STUCK ERROR MESSAGE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1