BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIKING SELECT

    MDR report key: 4954578 · Received July 30, 2015

    Report

    Report Number
    3010611950-2015-00004
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 8, 2015
    Manufacturer
    NATUS NEUROLOGY, INCORPORTAED
    Product Code
    IKN
    PMA / PMN Number
    K890495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    1) REGISTERED INTERNALLY AS A COMPLAINT (REFERENCE (B)(4)) FOR FURTHER INVESTIGATION BY MANUFACTURER. 2) THE EQUIPMENT WAS EVALUATED AT THE COMPLAINANTS LOCATION BY A TRAINED NATUS FIELD SERVICE TECHNICIAN AND FOUND TO BE OPERATING ACCEPTABLY . COMPONENTS RELATED TO ELECTRODE CONNECTION AND STIMULATING FUNCTIONS WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. TESTING INCLUDED ELECTRICAL AND STIMULUS FUNCTION TESTING. THAT EVALUATION CONCLUDED THAT THOSE COMPONENTS WERE FOUND TO BE OPERATING NORMALLY AND THERE WERE NO INDICATIONS THAT A MALFUNCTION OF THOSE COMPONENTS HAD CONTRIBUTED TO THE BURNS AT THE ELECTRODE SITES. 3) THE ELECTRODES USED IN CONJUNCTION WITH THIS EQUIPMENT WERE REPORTED UNDER A SEPERATE MDR (REFERENCE 3010611950-2015-00006). 4) ELECTRO-CAUTERY EQUIPMENT WAS IN USE BY THE COMPLAINANT AT THE SAME TIME AS THE NATUS DEVICE IN QUESTION. THERE ARE KNOWN RISKS ASSOCIATED WITH SUCH DEVICE TO DEVICE COMBINATIONS WHERE ELECTRODES CAN INTERCEPT STRAY RADIO FREQUENCY ENERGY AND RESULT IN THERMAL HEATING. NATUS SAFETY INFORMATION SUPPLIED TO END USERS STATES SUCH INTERACTIONS EXIST AND WARNS END USERS THAT ELECTRODE DISCONNECTION MAY BE NEEDED TO AVOID SUCH INTERACTIONS (REF NATUS SAFETY REFERENCE GUIDE, LABEL #(B)(4)).

    Description of Event or Problem · 1

    PATIENT WAS BURNED DURING SPINAL FUSION SURGERY AT THE SITE OF EMG STIMULATING ELECTRODES (ONE BURN ON LEFT ELBOW (~4MM X 3MM) AND TWO BURNS ON LEFT ANKLE (ONE A PINPOINT, THE SECOND ~ 5MM X 7MM)). PROCEDURE WAS 6 -- 7 HOURS. CUSTOMER WAS ALSO USING AN ELECTRO-CAUTERY INSTRUMENT (NOT A NATUS DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496366 VIKING SELECT ELECTROMYGRAPH IKN NATUS NEUROLOGY, INCORPORTAED 982A0403

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other