SHILEY

Description of Event or Problem

IT WAS REPORTED THAT A LEAK ALARM OCCURRED FROM THE ANESTHESIA MACHINE DURING PATIENT USE, SO EVEN AFTER REPLACING THE ANESTHESIA DEVICE MAIN UNIT AND ANESTHESIA CIRCUIT, THE LEAK ALARM PERSISTED. EVEN AFTER REPLACING PRODUCT OTHER THAN THE ONE IN QUESTION THE CAUSE COULD NOT BE DETERMINED. A LEAK WAS SUSPECTED IN THE INNER WALL OR OUTER WALL OF THE TRACHEAL TUBE.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: 125035, 125035 35FR LT BRONCO CATH PU CUFF X1 (LOT# UNKNOWN) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.