BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2101635 · Received May 11, 2011

    Report

    Report Number
    1720753-2011-07221
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 11, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE CABLE AND CARDS RELATED TO THE GENERATOR INTERFACE BOARD AND THE X-RAY GENERATOR WERE RESEATED. THE TUBE WAS REPAIRED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN OF THE SYSTEM FLICKERED AND WOULD NOT DISPLAY IMAGES INTERMITTENTLY AND THAT THE KILOVOLTAGE WENT TO THE MAXIMUM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1