BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3872732 · Received May 15, 2014

    Report

    Report Number
    1720753-2014-04230
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 15, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONTROLLER PCB WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXPERIENCED SYSTEM ERRORS RESULTING IN INTERMITTENT SYSTEM FUNCTIONALITY. SYSTEM FUNCTIONALITY WAS RECOVERABLE AFTER A SYSTEM REBOOT. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289749 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1