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

Model Number	8229708
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	12/19/2018
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 healthcare professional (hcp) reported via a manufacturer representative that the device was hooked up but the connections did not work prior to a procedure.A second tube was opened which worked.There was no patient involvement.
Additional Manufacturer Narrative
Analysis found that there was no anomaly in the construction of the device.The electrode wires would plug into a patent interface with no issues.A syringe was connected to the inflation luer and the cuff inflated / deflated 5 times (disconnecting and reconnecting the syringe each time).Electrically, the resistance of the tube electrodes from end to end shall be less than 200 ohms and the actual measurements were; red 17 ohms, red [w/white band] 8 ohms, blue 12 ohms, and blue [w/white band] 10 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.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from the healthcare professional via a manufacturer representative reported that after intubating the patient, the physician went to hook up the device to the monitor, however, what was normally seen did not appear.The physician gently manipulated the wire trying to get it to work and noticed that the wire worked intermittently but did not achieve a consistent connection.The patient was reintubated with a new device without further incident.There was no patient harm.

• 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: 8286314
• Report Number: 1045254-2019-00040
• Device Sequence Number: 1953203
• Product Code: ETN
• UDI-Device Identifier: 00643169782600
• UDI-Public: 00643169782600
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/11/2019

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: 07/10/2022
• Device Model Number: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0215817320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1