BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3880318 · Received April 8, 2014

    Report

    Report Number
    1720753-2014-03044
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 8, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. AS A PRECAUTION, THE CAMERA WAS REPLACED. 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 THEY WERE UNABLE TO VIEW FLUOROSCOPIC IMAGE BECAUSE THE LEFT MONITOR DISPLAYED A BLACK IMAGE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210892 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1