BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3231035 · Received July 12, 2013

    Report

    Report Number
    1720753-2013-08087
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PERFORMED A HIGH VOLTAGE AND FILAMENT CALIBRATION. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS MULTIPLE "MA ON IN ERROR" MESSAGES. THIS ERROR WILL LIKELY CAUSE THE SYSTEM TO SHUTDOWN UN-COMMANDED. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323235 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1