PURITAN BENNETT

Description of Event or Problem

IT WAS REPORTED THAT THE TEAM HEARD LEAKS AT THE ENDOTRACHEAL TUBE BALLOON (OTHER MANUFACTURER) AS IT WAS GLOATING. THE CUFF INDICATED A NUMBER AT 33, AND NO COMPENSATION FROM THE LATTER. THE NURSE CHECKED WITH THE PRESSURE GAUGE, THE BALLOON WAS DEFLATED, AND WAS REINFLATED WITHOUT SUCCESS. WHEN THE CUFF WAS REMOVED, THE PATIENT PRESENTED WITH VOMITING, INHALATION OF SECRETIONS INTO THE LUNGS, CARDIO RESPIRATORY ARREST AND COMPLETE PNEUMOTHORAX. AFTER A COMPLETE RESUSCITATION, THE PATIENT WAS REINTUBATED.

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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.