BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    MDR report key: 2883239 · Received December 21, 2012

    Report

    Report Number
    1045254-2012-00752
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 21, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE HAS BEEN RETURNED, BUT EVALUATION HAS NOT YET BEEN COMPLETED. METHOD: NO TESTING METHODS PERFORMED. RESULT: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    ONE (B)(4) NIM CONTACT ENDOTRACHEAL TUBE 6.0MM, LOT 0205919492 WAS RETURNED FOR EVALUATION. NO VISIBLE DAMAGES WERE NOTICED ON THE ELECTRODES OR THE WORKING LENGTH OF THE DEVICE. RESISTANCE READINGS WERE TAKEN WITH A FLUKE 21 MULTIMETER. RESISTANCE OF EACH LEAD IS TO BE BETWEEN 1.7 AND 3.7 OHMS. THE BLUE LEADS MEASURED 3.2' AND 3.1', AND THE RED LEADS MEASURED 3.0' AND 3.1'. THESE READINGS MEET THE REQUIRED MANUFACTURING SPECIFICATION. BASED ON THE ANALYSIS, THE COMPLAINT EVENT OF NOT RECEIVING A FUNCTIONAL RESPONSE COULD NOT BE CONFIRMED SINCE THE DEVICE APPEARED TO FUNCTION AS INTENDED. A CUFF WATER TEST WAS PERFORMED TO TEST FOR LEAKS. THE CUFF WAS INFLATED AND SUBMERGED, AND BUBBLES WERE VISIBLE INDICATING A LEAK IN THE CUFF. UNDER MAGNIFICATION, THE CUFF APPEARED TO HAVE A PIN-HOLE SIZE TEAR CLOSE TO THE PROXIMAL END. THE TEAR ON THE CUFF APPEARS TO BE MOST LIKELY RELATED WITH CUSTOMER HANDLING/USE OF THE DEVICE DURING USE.

    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 TO MEDTRONIC THAT AFTER THE ANESTHETIST INSERTED THE EMG TUBE, AN AIR LEAK WAS DISCOVERED AND THE TUBE WOULD NOT GIVE FUNCTIONAL RESPONSE. THERE WAS NO INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8229306 0205919492

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR