BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2820664 · Received November 2, 2012

    Report

    Report Number
    1720753-2012-09041
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 2, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE MONOBLOCK TUBE ASSEMBLY AND THE X-RAY CONTROLLER CIRCUIT BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED SEVERAL ERRORS, AMONG THEM AN "MA ON IN ERROR" MESSAGE, WHICH COULD CAUSE THE SYSTEM TO SHUT DOWN UNCOMMANDED. NO PATIENT 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