BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE

    MDR report key: 19030181 · Received April 3, 2024

    Report

    Report Number
    1045254-2024-00481
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 30, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. SECTION 4, PMA / 510(K): DEVICE NOT CLEARED OR SOLD IN THE US. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF THE TUBE FOUND THAT VISUALLY, THERE WAS CONTAMINATION ON DISTAL PORTIONS OF THE DEVICE INCLUDING THE CUFF BA LLOON AND ON THE PROXIMAL END OF THE INFLATION ASSEMBLY INCLUDING THE VALVE. FUNCTIONALLY, A SYRINGE WAS USED TO INJECT 20CC OF AIR INTO THE CUFF AND THERE WERE NO ISSUES DURING INFLATION OR DEFLATION. THE CUFF WAS RE-INFLATED AND DEFLATED MULTIPLE TIMES AND THE CUFF AND PILOT BALLOON WERE BOTH MANIPULATED BY APPLYING PRESSURE AND NO ISSUES WITH LEAKAGE WAS OBSERVED. FOR FURTHER ANALYSIS, A LEAK TEST WAS PERFORMED BY SUBMERGING THE ENTIRE DEVICE IN WATER AND NO BUBBLES (LEAKS) WERE OBSERVED. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. PREVIOUSLY APPLIED CODES OF FBM B21, FDR C21 AND FDC D16 ARE NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRA-OP, THE NIM EMG TUBE HAD AN AIR LEAK AND THE TUBE WAS EXTUBATED FROM THE PATIENT. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689223 NIM® EMG - ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229307J 0226945351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown