FISHER AND PAYKEL HEALTHCARE

Description of Event or Problem

A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED DURING USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED TO CONTINUE THERAPY AND THAT THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

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 PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED DURING USE ON A PATIENT. CONCLUSION: WITHOUT THE SUBJECT DEVICE BEING RETURNED FOR AN EVALUATION OR PHOTOGRAPHY FOR VISUAL INSPECTION, WE ARE UNABLE TO CONFIRM THE CAUSE OF THE REPORTED EVENT. ALL OPTIFLOW JUNIOR CANNULA ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS IS DISCARDED. IN ADDITION, SAMPLES ARE TAKEN FROM EACH PRODUCTION RUN AND PULL TESTED. IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS PUT ASIDE FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA HOW 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 CRUSH OR STRETCH TUBE."