(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing was returned to fph in (b)(4) for evaluation.It was visually inspected and pressure tested.Results: the rt265 infant breathing circuit was returned with disassembled elbow and swivel; however, no damaged was observed to either component.The swivel and elbow were reassembled and formed a tight fit when reconnected to the breathing circuit.The breathing circuit was subsequently pressure tested and the result was within specification.A lot check revealed no other complaints of this nature for lot number 160225.Conclusion: we were unable to determine what had caused the reported fault with the elbow and swivel of the subject infant breathing circuit.All rt265 infant 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 rt265 infant dual heated evaqua2 breathing circuit 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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