BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICOLET

    MDR report key: 3476724 · Received November 7, 2013

    Report

    Report Number
    3008289288-2013-00014
    Event Type
    Injury
    Date Received
    November 7, 2013
    Date of Event
    October 8, 2013
    Report Date
    November 6, 2013
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    GWJ
    PMA / PMN Number
    K905632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NICOLET SPIRIT WAS MANUFACTURED 11/1996 AND OBSOLETE IN 12/2004. NATUS BIOMED ENGINEER HAS CONTACTED THE DISTRIBUTOR TO DISCUSS THE EVENT AND PROVIDE GUIDANCE AS TO HOW TO USE OUR DEVICE WHILE USING ELECTRICAL SURGICAL UNITS. IN RESPONSE TO THIS INCIDENT, NATUS TECHNICAL SERVICE ALSO ADVISED CUSTOMER TO TAKE UNIT OUT OF SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE PRESENCE OF SURGICAL BURNS ON A PT'S SKIN AT SITE WHERE THE MAIN ELECTRODES WERE PLACED DURING A STANDARD IOM PROCEDURE. CUSTOMER REPORTS USING A NICOLET SPIRIT SYSTEM AS WELL AS AN ELECTRICAL SURGICAL UNIT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576723 NICOLET NICOLET SPIRIT GWJ NATUS NEUROLOGY INCORPORATED SPIRIT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other