BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    MDR report key: 3093488 · Received May 6, 2013

    Report

    Report Number
    1045254-2013-00361
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. PATIENT WAS EXTUBATED AND RE-INTUBATED DURING PROCEDURE. (B)(4) EVALUATION SUMMARY: RECEIVED ONE SAMPLE(S) WITH ORIGINAL PRODUCT POUCH / LABEL IDENTIFYING PART NUMBER AS 8229307 - NIM EMG ENDOTRACHEAL TUBE 7.0MM ID FROM LOT NUMBER 0206059155. THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF RESIDUE ON THE CUFF. READINGS WERE TAKEN; BOTH BLUE AND RED LEADS MEASURED BETWEEN 2.9¿ AND 3.0¿. THESE READINGS MEET SPECIFICATIONS. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. ALTHOUGH THE DEVICE MEETS THE REQUIRED RESISTANCE / CONTINUITY SPECIFICATION, IT IS LIKELY THAT CUSTOMER MISUSE / HANDLING OF THE DEVICE DURING PROCEDURE CONTRIBUTED TO THE COMPLAINT EVENT AND RESULTED IN LOSS OF SIGNAL OR POOR/NO STIMULATION RESPONSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIGNAL WAS NORMAL WHEN SURGEON TESTED THE NIM 3.0, BUT NERVE DETECTION WAS LOST DURING SURGERY; WHEN SURGEON REPLACED WITH ANOTHER ENDOTRACHEAL TUBE, REINTUBATED, DETECTION FUNCTION WAS RESTORED, THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196670 ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229307 0206059155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other