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

Model Number	8229975
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via manufacturer representative that after the endotracheal tube was placed in the patient, the mainframe detected that in channel number one there was no good signal and a red cross appeared on the screen of the mainframe while channel number two showed normal and good values during the thyroid procedure.The wires from both channels were switched.The red cross now appeared on channel number two.The reported endotracheal tube was extubated and another tube was used to complete the procedure.This was not the first time the endotracheal tube was used.The procedure was delayed when the second tube was positioned.
Additional Manufacturer Narrative
Analysis found no damage or anomalies in the construction of the device that would have resulted in the reported event.The drawing requires each circuit to be less than 20 ohms and contain no short circuit between poles.The actual readings were as follows; red 18 ohms, red with band 17, blue 19 ohms, and blue with band 18 ohms.There were no short circuits or out of specification condition identified.(b)(4) are no longer applicable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via a manufacturer representative that the endotracheal tube was used for the first time.

• 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: 7935957
• Report Number: 1045254-2018-00475
• Device Sequence Number: 940664
• Product Code: ETN
• UDI-Device Identifier: 00643169358812
• UDI-Public: 00643169358812
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/13/2018

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: 02/13/2022
• Device Model Number: 8229975
• Device Catalogue Number: 8229975
• Device Lot Number: 0214914981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75