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U.S. Department of Health and Human Services

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

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MEDTRONIC OPHTHALMICS . MEDTRONIC XOMED NIM EMG ENDOTRACHEAL TUBE ENDO TRACHEAL TUBE/NERVE MONITOR SIZE 6.0 Back to Search Results
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.

 
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Brand NameMEDTRONIC XOMED NIM EMG ENDOTRACHEAL TUBE
Type of DeviceENDO 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 Key744619
MDR Report Key756730
Event Key721320
Report Number756730
Device Sequence Number1
Product CodeBTR
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 Received08/15/2006
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue Number8229306
Device LOT Number41308900
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/15/2006
Device Age1 dy
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 08/15/2006 Patient Sequence Number: 1
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