BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3832632 · Received March 27, 2014

    Report

    Report Number
    1720753-2014-02727
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE KEY SWITCH CABLE ASSEMBLY WAS EVALUATED AND REPLACED. THE GPOS WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED KEY SWITCH STUCK ERROR MESSAGE. THE PREVENTED THE SYSTEM FROM FUNCTIONING TEMPORARILY RESULTING IN RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THER EIS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179339 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1