BEUDAMED
    FDA Adverse Event Other Summary report: N

    NICOLETONE VEEG 44 CHANNEL ETERNET DIGITAL VI

    MDR report key: 2485177 · Received March 7, 2012

    Report

    Report Number
    3008289288-2010-00001
    Event Type
    Other
    Date Received
    March 7, 2012
    Date of Event
    February 2, 2010
    Report Date
    March 3, 2010
    Manufacturer
    CAREFUSION 209 INC.
    Product Code
    GWQ
    PMA / PMN Number
    K991054
    Removal / Correction Number
    2126317/03/02/2010/001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR UNITS IN THE FIELD, WE WILL NOTIFY USERS ABOUT THE R/L PROTOCOLS AND INSTRUCT THEM TO BE REMOVED FROM THE PROTOCOLS MENU IF THEY ARE NOT UTILIZED AND PROPERLY UNDERSTAND BY THE USER FACILITY AND STAFF. ONE PT UNDERWENT BILATERAL ELECTRODE GRID PLACEMENT WHEN UNILATERAL GRID PLACEMENT MAY HAVE SUFFICED. THE USER FACILITY ALSO SUBMITTED A MEDWATCH REPORT (B)(4). THIS REPORT WAS EDITED ON 3/6/2012 TO REVISE THE REGISTRATION NUMBER FROM 2126317 TO 3008289288. THE CURRENT REGISTRATION NUMBER WAS NOT KNOWN AT THE TIME THE INITIAL MDR WAS SENT.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED INDICATING THAT THE USER HAD DISCOVERED THAT EEG DATA FROM ELECTRODES PLACED ON THE RIGHT SIDE OF THE HEAD DISPLAYED IN THE EEG RECORD AS HAVING COME FROM THE LEFT SIDE OF THE HEAD AND VISA VERSA. INVESTIGATION DETERMINED THAT THE CUSTOMER SELECTION AND USE OF THE "ROUTINE V44 R/L" PROTOCOL (R/L REFERS TO THE RIGHT SIDE ELECTRODES DISPLAYED OVER THE LEFT SIDE ELECTRODES) WITHOUT THE ASSOCIATED AMPLIFIER OVERLAY MAY RESULT IN A MISMATCH BETWEEN THE AMPLIFIER LABELING AND THE PROTOCOL. THIS MAY RESULT IN THE MISINTERPRETATION OF THE LEFT VERSUS RIGHT SIDE OF THE BRAIN. IN ONE CASE, A PT UNDERWENT BILATERAL GRID PLACEMENT SURGERY WHEN UNILATERAL GRID PLACEMENT WOULD HAVE SUFFICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLETONE VEEG 44 CHANNEL ETERNET DIGITAL VI NICOLETONE GWQ CAREFUSION 209 INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other EVALUATED ON CUSTOMER SITE.