(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuits were not received at fph in (b)(4) for evaluation.Instead, two sealed rt380 adult dual heated evaqua2 breathing circuit kits were returned and visually inspected.One rt380 breathing circuit kit was opened for pressure testing.Questions were also sent to the customer however no response was received despite at least one follow-up attempt.Results: visual inspection revealed no damage to the sealed breathing circuits.The pressure test result was within specification.Conclusion: we were unable to determine what may have caused the fault as reported by the customer as no complaint devices were returned for investigation.No fault was found with the returned sealed devices.All rt380 adult dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state: "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." "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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