BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1890917 · Received October 28, 2010

    Report

    Report Number
    1720753-2010-03791
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND PERFORMED A TUBE CALIBRATION. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYED A LOW MA ERROR WHEN THE FOOT PEDAL IS PRESSED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1