BEUDAMED
    FDA Adverse Event Summary report: N

    NICOLET ONE NEEG

    MDR report key: 2502466 · Received March 21, 2012

    Report

    Report Number
    2502466
    Date Received
    March 21, 2012
    Date of Event
    January 2, 2012
    Report Date
    March 21, 2012
    Manufacturer
    CAREFUSION
    Product Code
    GWQ
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    REPORTED TO THE CLINICAL ENGINEERING MANAGER THAT "NICOLET EEG EQUIPMENT IS FREQUENTLY BUMPED OFF LINE, SEVERAL TIMES PER DAY, IN THE MIDDLE OF PROCEDURES...IN THE OR DURING CASES... WE'VE BEEN WORKING DIRECTLY WITH THE OEM UNDER OUR CONTRACT... FYI"THE CLINICAL ENGINEERING MANAGER PROMPTLY VISITED AND ASKED THE STAFF TO COMPLETE INCIDENT REPORTS EVERY TIME THIS OCCURS AND TO PLEASE NOTIFY US TO WORK WITH BOTH THE OEM AND THE HOSPITAL'S IS NETWORK TEAMS IN ORDER TO RESOLVE THIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET ONE NEEG SYSTEM, EEG MONITORING GWQ CAREFUSION NICOLETONE NEEG *
    2 NICOLET ONE NEEG SYSTEM, EEG MONITORING GWQ CAREFUSION NICOLETONE NEEG *
    3 NICOLET ONE NEEG SYSTEM, EEG MONITORING GWQ CAREFUSION NICOLETONE NEEG *

    Patients

    Seq Age Sex Outcome Treatment
    1 *