MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE

Model Number	8229738
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative about the dysfunction of device's tubing.There was no patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow up, it was confirmed that the device did not work after doing all the troubleshooting.They also noted that there were visual and audible indications being displayed and the procedure was completed.
Additional Manufacturer Narrative
Analysis found that the machine adapter was detached when received however it was reinserted into the tube and remained secure.The cuff inflates and deflates with no issue or leakage.Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The biological contaminants were cleaned off the emg contacts prior to electrical testing.Electrically, the resistance of the tube electrodes from end to end shall be less than 200 ohms and the actual measurements were; red 13 ohms, red [w/white band] 20 ohms, blue 23 ohms, and blue [w/white band] 13 ohms.There were no shorts between circuits or intermittent behavior while manipulating the circuits.When viewed under magnification, there were no cracks in the electrode contacts.There was no fault found with the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8204496
• Report Number: 1045254-2018-00753
• Device Sequence Number: 19250048
• Product Code: ETN
• UDI-Device Identifier: 00643169782655
• UDI-Public: 00643169782655
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: 8229738
• Device Catalogue Number: 8229738
• Device Lot Number: 0214863357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 03/08/2019; 08/19/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 04/04/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1