FISHER AND PAYKEL HEALTHCARE

Additional Manufacturer Narrative

(B)(4). CORRECTION: SECTION B5: UPDATED THE DESCRIBE EVENT OR PROBLEM WITH PATIENT CONSEQUENCES. SECTION G4: PMA/510(K) NUMBER - NO 510(K) NUMBER INCLUDED DUE TO THE SUBJECT DEVICE BEING EXEMPT FROM PMS PATHWAY TO REGULATORY APPROVAL. METHOD: THE SUBJECT DEVICE, OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPHY PROVIDED BY THE DISTRIBUTOR AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: EVALUATION OF THE PROVIDED PHOTOGRAPHY CONFIRMED THAT ONE THE TUBES WAS DETACHED FROM THE CANNULA. ADDITIONALLY, IT WAS OBSERVED THAT PART OF THE CONNECTOR (SWIVEL GRIP) WAS MISSING. CONCLUSION: BASED ON THE EVALUATION OF PHOTOGRAPHY PROVIDED, AND OUR KNOWLEDGE OF THE PRODUCT, IT IS MOST LIKELY THAT THE REPORTED EVENT RESULTED FROM THE CANNULA BEING SUBJECTED TO EXCESSIVE FORCE. THE MISSING PART IN THE CONNECTOR MAY HAVE BEEN REMOVED TO ENABLE CONNECTION TO A BREATHING CIRCUIT OTHER THAN THE ONE RECOMMENDED IN THE USER INSTRUCTIONS. THE SUBJECT DEVICE IS INTENDED TO BE USED WITH F&P RT330 OPTIFLOW¿ JUNIOR BREATHING CIRCUIT KIT WHEN USED WITH MR850 HEATED HUMIDIFIER. AS PART OF THE MANUFACTURING PROCESS, ALL OPTIFLOW JUNIOR CANNULAS ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS SPECIFICATIONS IS DISCARDED. IN ADDITION, REPRESENTATIVE SAMPLES FROM EACH BATCH ARE FUNCTIONALLY TESTED TO ASSESS RETENTION STRENGTH BETWEEN THE ASSEMBLED COMPONENTS. IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS QUARANTINED FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPTIFLOW JUNIOR NASAL CANNULA SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT AND FITTING OF THE CANNULA, AND PROVIDE THE FOLLOWING WARNINGS: APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH. DO NOT STRETCH OR CRUSH TUBE." "ENSURE THAT ALL CONNECTIONS ARE SECURE DUNG USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED. UNDER EXCESSIVE LOAD, THE CANNULA MAY DISCONNECT TO PREVENT FORCES BEING TRANSFERRED TO THE PATIENT.

Description of Event or Problem

A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF THE OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM CANNULA END DURING USE. THE HEALTHCARE FACILITY REPORTED A TEMPORARY DROP IN THE PATIENT'S OXYGEN SATURATION. IT WAS ALSO REPORTED THAT THE SUBJECT DEVICE WAS IMMEDIATELY REPLACED TO CONTINUE THE THERAPY, WITH NO FURTHER REPORTED PATIENT CONSEQUENCES.

Additional Manufacturer Narrative

(B)(4) SECTION G4: PMA/510(K) NUMBER - NO 510(K) NUMBER INCLUDED DUE TO THE SUBJECT DEVICE BEING EXEMPT FROM PMS PATHWAY TO REGULATORY APPROVAL. METHOD: THE SUBJECT DEVICE, OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPHY PROVIDED BY THE DISTRIBUTOR AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: EVALUATION OF THE PROVIDED PHOTOGRAPHY CONFIRMED THAT ONE THE TUBES WAS DETACHED FROM THE CANNULA. ADDITIONALLY, IT WAS OBSERVED THAT PART OF THE CONNECTOR (SWIVEL GRIP) WAS MISSING. CONCLUSION: BASED ON THE EVALUATION OF PHOTOGRAPHY PROVIDED, AND OUR KNOWLEDGE OF THE PRODUCT, IT IS MOST LIKELY THAT THE REPORTED EVENT RESULTED FROM THE CANNULA BEING SUBJECTED TO EXCESSIVE FORCE. THE MISSING PART IN THE CONNECTOR MAY HAVE BEEN REMOVED TO ENABLE CONNECTION TO A BREATHING CIRCUIT OTHER THAN THE ONE RECOMMENDED IN THE USER INSTRUCTIONS. THE SUBJECT DEVICE IS INTENDED TO BE USED WITH F&P RT330 OPTIFLOW¿ JUNIOR BREATHING CIRCUIT KIT WHEN USED WITH MR850 HEATED HUMIDIFIER. AS PART OF THE MANUFACTURING PROCESS, ALL OPTIFLOW JUNIOR CANNULAS ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS SPECIFICATIONS IS DISCARDED. IN ADDITION, REPRESENTATIVE SAMPLES FROM EACH BATCH ARE FUNCTIONALLY TESTED TO ASSESS RETENTION STRENGTH BETWEEN THE ASSEMBLED COMPONENTS. IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS QUARANTINED FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPTIFLOW JUNIOR NASAL CANNULA SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT AND FITTING OF THE CANNULA, AND PROVIDE THE FOLLOWING WARNINGS: APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH. DO NOT STRETCH OR CRUSH TUBE." "ENSURE THAT ALL CONNECTIONS ARE SECURE DUNG USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED. UNDER EXCESSIVE LOAD, THE CANNULA MAY DISCONNECT TO PREVENT FORCES BEING TRANSFERRED TO THE PATIENT.

Description of Event or Problem

A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF THE OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM CANNULA END DURING USE. IT WAS ALSO REPORTED THAT THE SUBJECT DEVICE WAS IMMEDIATELY REPLACED TO CONTINUE THE THERAPY, WITH NO FURTHER REPORTED PATIENT CONSEQUENCES.