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

Model Number	8229507
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been discarded by the customer and will not be returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that interoperative, there was an inflation/deflation issue with the endodtracheal tube cuff.Patient reintubation was required.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7430332
• Report Number: 1045254-2018-00159
• Device Sequence Number: 13940628
• Product Code: ETN
• UDI-Device Identifier: 00643169789562
• UDI-Public: 00643169789562
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: 8229507
• Device Catalogue Number: 8229507
• Device Lot Number: 0214081175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention