(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was 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.Results: visual inspection of the photograph provided by the customer shows that the swivel elbow and wye have disassembled.No damages were observed to any of the swivel components.Conclusion: without the complaint device, we could not determine what caused the rt265 swivel to diassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.All rt265 dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt265 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit 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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