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Patient 1
PHOTOGRAPHS OF THE DEVICE WERE PROVIDED, WHICH SHOW THAT THE PRODUCT TANK'S PLASTIC CAP IS BROKEN, WHICH IS INDICATIVE THAT AN OVER-PRESSURIZATION EVENT OCCURRED. HOWEVER, THE PRODUCT TANK ITSELF APPEARS TO BE INTACT AND REMAINS IN ITS INTENDED POSITION WITHIN THE DEVICE. THE TUBING COMING OFF THE SIEVE BED CAPS APPEARS TO BE DISCOLORED AND SIEVE MATERIAL IS PRESENT WITHIN THE TUBING. THIS INCIDENT IS BEING REPORTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION, BASED ON THE EVIDENCE THAT THE PRODUCT TANK EXPERIENCED AN OVER-PRESSURIZATION EVENT. THIS FAILURE MODE HAS BEEN PREVIOUSLY IDENTIFIED AND INVESTIGATED. THE INVESTIGATION ACTIVITIES CONCLUDED THAT THE FAILURE IS UNLIKELY TO OCCUR WHEN THE SYSTEM IS OPERATING UNDER NORMAL CONDITIONS OR A SINGLE FAULT CONDITION. RATHER, THE SYSTEM LIKELY HAS TO EXPERIENCE MULTIPLE FAULTS TO RESULT IN THE FAILURE OBSERVED. EVEN THOUGH THE FAILURE IS UNLIKELY TO OCCUR, COMPONENTS OF THE IRC5PO2V CONCENTRATOR HAVE BEEN UPDATED TO PREVENT POTENTIAL RECURRENCE OF THIS ISSUE. THE SUBJECT CONCENTRATOR WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THESE UPDATES. THE CONCENTRATOR WAS RETURNED TO INVACARE AND IS PENDING FURTHER EVALUATION. ONCE THE EVALUATION RESULTS ARE AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.