(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the provided photograph identified a puncture in the inspiratory limb.Conclusion: we are unable to determine the cause of the reported event.However, based on our investigation, it is most likely due to the tube being cut with a sharp object.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 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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