BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1279645 · Received January 7, 2009

    Report

    Report Number
    1720753-2008-21512
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    May 1, 2008
    Report Date
    May 12, 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

    THE SERVICE CALL WAS CANCELLED BY THE CUSTOMER. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROL PANEL ON THE 9800 SYSTEM WOULD NOT WORK DURING A CASE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1