(b)(6).Device mfr date: (b)(6) (b)(6) 2014 (b)(6) (b)(6) 2015 (b)(6) (b)(6) 2015 method: eight of the nine complaint (b)(4) infant dual heated evaqua2 breathing circuits were returned to fph in (b)(6) and were pressure tested for leaks.The unit without lot number, as specified above, was not returned to fph for inspection.An attempt was also made to obtain additional information regarding the reported complaint but no response was received from the healthcare facility.Results: no fault was found with the returned (b)(4) infant breathing circuits during pressure test.The test results were within specification.A lot check revealed no other complaints of this nature for lot numbers 141022, 150113, 150129 and 150211.Conclusion: the leak reported by the healthcare facility was not replicated during inspection.We are therefore unable to determine what may have caused the reported problem.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested prior to distribution, and those that fail are rejected.The subject rt266 infant breathing circuit would have met the required specifications at the time of production.This suggests the leak occurred post production.The user instructions that accompany the rt266 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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