MAUDE Adverse Event Report: MEDTRONIC OPHTHALMICS .MEDTRONIC XOMED NIM EMG ENDOTRACHEAL TUBEENDO TRACHEAL TUBE/NERVE MONITOR SIZE 6.0

Catalog Number 8229306

Event Date 04/05/2006

Event Type  Malfunction  

Event Description

After patient was intubated, lines were plugged into the nerve monitor. Line 2 was not giving a reading. Et tube changed and new tube worked fine. Troubleshooting done before the tube was changed, which included checking that the lines were plugged in correctly and anesthesia tried turning tube.

• Brand Name: MEDTRONIC XOMED NIM EMG ENDOTRACHEAL TUBE
• Type of Device: ENDO TRACHEAL TUBE/NERVE MONITOR SIZE 6.0
• Manufacturer (Section F): MEDTRONIC OPHTHALMICS .; a division of medtronic xomed,; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section D): MEDTRONIC OPHTHALMICS .; a division of medtronic xomed,; 6743 southpoint drive north; jacksonville FL 32216
• Device Event Key: 744619
• MDR Report Key: 756730
• Event Key: 721320
• Report Number: 756730
• Device Sequence Number: 1
• Product Code: BTR
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2006

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/15/2006
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 8229306
• Device LOT Number: 41308900
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2006
• Device Age: 1 dy
• Event Location: Hospital
• Is the Device an Implant?: No
• Is this an Explanted Device?: No Answer Provided