Ps(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and pressure tested.Results: visual inspection of the complaint rt380 adult dual-heated evaqua2 breathing circuit revealed no damage to the returned breathing circuit or the dryline.The pressure test also revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the failed leak test as reported by the customer, as no fault was found with the returned device.The reported leak most likely occurred due to a loose connection in the setup or as the water feedset of the mr290 vented autofeed humidification chamber was still in the feedset winder and not connected to a water bag when the leak test was performed.The feedset winder is designed to secure the feedset and spike during transport and storage.It is not designed to seal the spike.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 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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