(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fph in (b)(4), and was visually inspected.Results: visual inspection revealed the dryline was split, near the ventilator end connector.The edges of the split were rough.Conclusion: we were unable to determine what may have caused the damage observed on the dryline of the returned infant breathing circuit.All rt265 infant dual heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production.All drylines are also leak tested during production.Any breathing circuit or dryline which fails any of these tests is discarded.The dryline of the subject infant breathing circuit would have met the required specification at the time of production.Moreover, the hospital reported that the damage occurred after a period of use, which suggests that the observed splitting occurred after the subject infant breathing circuit was released for distribution.Our user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuits 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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