DAR

Description of Event or Problem

IT WAS REPORTED THAT THE NURSE ROUTINELY REPLACED THE BREATHING CIRCUIT AND VENTILATOR TUBING. ONE HOUR LATER, THE BEDSIDE NURSE DISCOVERED CONDENSATE LEAKING FROM THE CONNECTION BETWEEN THE BREATHING CIRCUIT AND THE ENDOTRACHEAL TUBE, INDICATING POOR SEALING AT THE INTERFACE. THE BREATHING CIRCUIT WAS IMMEDIATELY REPLACED. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

Additional Manufacturer Narrative

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.