BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3921277 · Received June 6, 2014

    Report

    Report Number
    1720753-2014-04807
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE BOARDS AND POWER SUPPLY CONNECTORS WERE RESEATED DURING THE SERVICE CALL. 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 THE FLUOROSCOPIC IMAGE WAS UNABLE TO VIEWED AND FUNCTIONALITY WAS RECOVERED BY A SYSTEM REBOOT. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331629 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1