BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 4122096 · Received September 19, 2014

    Report

    Report Number
    1720753-2014-08034
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY CONNECTOR WAS EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE POWER INTERMITTENTLY SHUT DOWN. FUNCTIONALITY WAS RECOVERED AFTER A REBOOT. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583228 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1