(b)(4), the rt206 adult inspiratory heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt206 adult inspiratory heated breathing circuit was not returned to fisher & paykel healthcare (f&p) in new zealand.Our investigation is thus based on the information provided by the customer, and our knowledge of the product.Results: the healthcare facility reported that the rt206 adult inspiratory heated breathing circuit triggered a leakage alarm after 1 day and 5 hours of use.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.All rt206 adult inspiratory heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt206 adult inspiratory heated breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged." "check that the heater wire is evenly distributed along the circuit and not bunched or kinked." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
|