BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2181527 · Received July 7, 2011

    Report

    Report Number
    1720753-2011-08815
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 7, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE UNIVERSAL NODE BOARD WAS REPLACED. THE CALIBRATION FILES WERE RELOADED. THE CONNECTORS WERE TIGHTENED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PERFORM FLUOROSCOPY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1