BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICOLET VIKING III

    MDR report key: 538249 · Received August 2, 2004

    Report

    Report Number
    538249
    Event Type
    Malfunction
    Date Received
    August 2, 2004
    Date of Event
    July 15, 2004
    Report Date
    August 2, 2004
    Manufacturer
    NICOLET BIOMEDICAL
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING SSEP, SOMATOSENSORY EVOKED POTENTIALS, MONITORED WHILE UNDERGOING SPINAL LAMINECTOMY/FUSION. VERY EARLY IN THE CASE THE MACHINE BECAME INOPERABLE. THE ENTIRE MACHINE WAS PULLED FROM THE ROOM AND THE JACK BOX WAS REPLACED. THE MACHINE WAS BROUGHT BACK INTO SERVICE AND WORKED CORRECTLY FOR THE REMAINDER OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET VIKING III SSEP MONITOR GWF NICOLET BIOMEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR