(b)(4).Method: the complaint rt266 infant dual-heated evaqua2 breathing circuits was returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected.Results: visual inspection of the complaint rt266 infant dual-heated evaqua2 breathing circuit revealed the extension tubing cuff was found split.Conclusion: we are unable to determine the cause of the split.All rt266 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 rt266 infant dual-heated evaqua2 breathing circuit state the following: "this product is intended to be used for a maximum of 7 days." "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure." "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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