BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 4240018 · Received November 3, 2014

    Report

    Report Number
    1720753-2014-09119
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    November 3, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM NOTES WERE 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 INTERMITTENT COMMUNICATION FAILED ERROR MESSAGES THAT RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. SYSTEM FUNCTIONALITY WAS RECOVERABLE FOLLOWING A REBOOT. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703586 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1