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

Model Number	8229970
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
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 health care provider (hcp) reported via a manufacturer representative that they have not received information from the mainframe after having placed the tube in the patient's throat during the procedure.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that there was a residue consistent with biological contaminants on both devices.The drawing requires each circuit to be less than 20 ohms and contain no short circuit between poles.The actual readings for 1 sample were; red 12 ohms, red with band 11, blue 12 ohms, and blue with band 13 ohms.The actual readings for the other sample were; red 16 ohms, red with band 14, blue 12 ohms, and blue with band 11 ohms.There were no short circuits or out of specification condition identified with either tube.Visually, the flex circuits on both tubes were bent and creased.The green and red/white subdermal needle assembly shall exhibit continuity from needle top to connecting pin with resistance being less than 2.5 ohms.The resistance measured between 0.7 and 0.8 ohms indicating an in-specification condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received stated that during the check up for tube position after the airway was established, in control of electrode part, all crosses were red whereas the tube was correctly positioned and cables wired; the patient interface and return electrodes on patient breast, too.A second tube was used but, the issue was not resolved.Then, took a third tube with a different lot number and finally, all the crosses became green.They lost time but there was no patient impact and the case was completed.The issue repeated all week when tube in the same lot number was used; even with the same mainframe and different medical staff.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8112005
• Report Number: 1045254-2018-00664
• Device Sequence Number: 14018481
• Product Code: ETN
• UDI-Device Identifier: 00643169358805
• UDI-Public: 00643169358805
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K925640
• 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): 03/18/2019

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: 03/05/2022
• Device Model Number: 8229970
• Device Catalogue Number: 8229970
• Device Lot Number: 0215030033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/22/2019; 02/19/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 02/18/2019; 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1