(b)(4).Section g4: the rt200 adult dual 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.Section h11: method: the subject rt200 adult dual heated breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a rt200 adult dual heated breathing circuit failed the ventilator leak test prior to patient use.Conclusion: the subject rt200 adult dual heated breathing circuit was requested to be returned for evaluation, however, it was not provided.Without the return of the complaint device, we are unable to confirm, or determine the cause of the reported fault.All rt200 adult dual heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt200 adult dual heated breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - "check all connections are tight before use." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
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