BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

    MDR report key: 2954999 · Received February 11, 2013

    Report

    Report Number
    1045254-2013-00085
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED (B)(4) 2013. THE PRODUCT WAS RETURNED FOR EVALUATION BY THE QUALITY ENGINEERING TEAM. ONE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL BOX AND PRODUCT LABEL. THE TUBE WAS REPORTED TO BE AN (B)(4) INT L EMG ENDOTRACHEAL TUBE, 8.0MM. THE SIZE WAS CONFIRMED BY THE STAMPINGS ON THE INFLATION BALLOON, '8.0MM.' THE TUBE WAS COMPARED TO DRAWING (B)(4), TRACHEAL TUBE, REINFORCED PVC, ASSEMBLY, REV H. THIS ITEM HAS A FLEX CIRCUIT WITH NON-WIRE ELECTRODES. THE RESISTANCE WAS MEASURED AS PER DRAWING (B)(4) EMG ET TUBE HARNESS, REV G, NOTE 2 AND 3. 'MAXIMUM RESISTANCE FROM ELECTRODES TO PINS: 20 OHMS.' OPEN CIRCUIT (>20 M OHMS) BETWEEN PINS. MEASUREMENTS WERE TAKEN WITH A FLUKE 21 MULTIMETER, ASSET # (B)(4) 2013. THE RESISTANCE READINGS WERE ERRATIC AND RANGED BETWEEN 40-106 OHMS. THERE WERE VISIBLE CREASES NOTICED ON THE FLEX CIRCUIT TAIL WHICH LIKELY CAUSED THE ERRATIC READINGS. DUE TO THE DEFECT OBSERVED ON THE RETURNED DEVICE, THE COMPLAINT EVENT COULD NOT BE DUPLICATED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PMA: 510(K) - THIS PRODUCT IS LICENSED FOR OUS SALE/DISTRIBUTION ONLY BUT IS SIMILAR TO K925640. THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE EMG TUBE WAS NOT RESPONDING TO STIMULUS. ALL CONNECTIONS WERE CHECKED AND CONFIRMED TO BE WORKING. THE ANESTHESIOLOGIST CHECKED THE POSITION OF THE EMG TUBE AND ATTEMPTED TO STIMULATE THE VAGUS NERVE BUT THE EMG TUBE SHOWED NO RESPONSE SIGNAL. A VIDEO LARYNGOSCOPE WAS USED TO VISUALIZE THE EMG TUBE POSITION AND IT WAS CONFIRMED TO BE FINE. THE PHYSICIAN DECIDED TO USE 'NEEDLES FOR THE STIMULATION' AND WAS ABLE TO GET A SIGNAL FROM THE VAGUS NERVE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INJURY AND THE OUTCOME OF THE PROCEDURE WAS REPORTED TO BE 'GOOD.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59157 ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229980 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR