BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1191320 · Received October 9, 2008

    Report

    Report Number
    1720753-2008-22128
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 3, 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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING A CASE THE IRIS CLOSED, THERE WERE UNCOMMANDED X-RAYS, AND THE SYSTEM LOCKED UP. NO INJURY TO PT OCCURRED. SYSTEM WAS REBOOTED TO CORRECT ERROR AND COMPLETE THE CASE WITH NO FURTHER PROBLEMS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1