(b)(4).Method: none of the six complaint devices were returned for investigation, however 32 sealed rt265 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare for evaluation.Results: the swivel elbows and swivel wyes of all 32 rt265 breathing circuits were found fully assembled.Conclusion: without the complaint devices, we could not determine what caused the rt265 swivels to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.All rt265 infant 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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