BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICOLET NIC VUE

    MDR report key: 1601322 · Received December 9, 2009

    Report

    Report Number
    1601322
    Event Type
    Malfunction
    Date Received
    December 9, 2009
    Date of Event
    November 9, 2009
    Report Date
    November 30, 2009
    Manufacturer
    CAREFUSION 209, INC.
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL USES A NIC VUE SYSTEM CONSISTING OF EEG MACHINE WHICH MAY BE USED ANYWHERE IN THE HOSPITAL, AND AN EEG WORKSTATION ON WHICH EEG STUDIES ARE STORED AND REVIEWED. THE EEG MACHINE IS DESIGNED TO COMMUNICATE WITH THE WORKSTATION VIA THE HOSPITAL'S LAN. THE POLICY OF THE HOSPITAL'S IT DEPARTMENT IS THAT ANY SYSTEM CONNECTING TO THE HOSPITAL NETWORK MUST HAVE THE CORPORATE ANTI-VIRUS SOFTWARE (MCAFEE) LOADED ON IT. USING INFORMATION PROVIDED BY NICOLET, THE HOSPITAL IT GROUP WAS ABLE TO LOAD THIS SOFTWARE PROTECTION ON THE EEG WORKSTATION, AND CONFIGURE IT ACCORDING THE THE NICOLET RECOMMENDATIONS. HOWEVER THE HOSPITAL'S IT DEPARTMENT CONSIDERS THE EEG MACHINE ITSELF TO BE A MEDICAL DEVICE, AND THEIR POLICY PROHIBITS THEM FROM INSTALLING SUCH ANTIVIRUS SOFTWARE ON A MEDICAL DEVICE.THE BIOMEDICAL ENGINEERING DEPARTMENT HAS TESTED A COMMERCIALLY PURCHASED VERSION OF MCAFEE ANTIVIRUS SOFTWARE ON THE EEG MACHINE, AND FOUND THAT IT BLOCKED COMMUNICATION WITH THE NETWORKED WORKSTATION. THE HOSPITAL'S IT GROUP MAY HAVE THE EXPERTISE TO PROPERLY CONFIGURE ANTIVIRUS SOFTWARE ON THE EEG MACHINE, AS THEY DID THE WORKSTATION, BUT FEELS THAT IT IS NOT APPROPRIATE FOR THEM TO INSTALL OR CONFIGURE SOFTWARE ON A MEDICAL DEVICE.AT THIS TIME THE EEG MACHINE IS BEING USED, UNPROTECTED, ON THE HOSPITAL NETWORK, IN ORDER THAT IT CAN OPERATE PROPERLY AND COMMUNICATE WITH THE WORKSTATION. WE BELIEVE THAT OTHER FACILITIES MAY ENCOUNTER SIMILAR ISSUES AS THE NUMBER OF MEDICAL DEVICES CONNECTING WITH HOSPITAL LAN'S CONTINUES TO INCREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET NIC VUE EEG WORKSTATION GWQ CAREFUSION 209, INC. NCM107933 *
    2 NICOLET NIC VUE EEG MACHINE GWQ CAREFUSION 209, INC. NCM108198 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *