(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the customer's description of event, photography and our knowledge of our product.Conclusion: the customer reported that the swivel of the rt266 disassembled.Without the complaint device, we could not determine what caused the rt266 swivel to diassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.All rt266 dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt266 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuits also state 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." "set appropriate ventilator alarms.'.
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