BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3943767 · Received April 30, 2014

    Report

    Report Number
    1720753-2014-03793
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE IMAGE PROCESSOR BOARD AND VIDEO CONTROL BOARD WERE REPLACED DURING SERVICE. THE COAX CONNECTOR AND INTERCONNECT CABLE WERE RESEATED. 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 IMAGES PRODUCED WERE WHITE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258474 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1