(b)(4).Method: the complaint rt380 adult evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in (b)(4) for investigation.This device was visually inspected.Results: the inspiratory limb was returned with the elbow and the patient end connector loose.Conclusion: we were unable to determine conclusively the cause of the reported event.However, it is possible that the circuit was cleaned and reused which could lead to the reported event.Rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.If any faults are detected the whole batch is placed on hold for investigation.The user instructions that accompany the rt380 breathing circuit state the following: check all connections are tight before use.Set appropriate ventilator alarms.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand.
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