(b)(4).Method: two rt134 non-heated adult breathing circuits were returned to fisher & paykel healthcare in (b)(4) for evaluation.They were pressure tested and subsequently submerged in a water bath to test for leak.Results: pressure test revealed that both of the returned circuits exhibited leak and were out of specification.The water bath test showed that the leak on both of the returned circuits is through the connection between the lid and bowl of the inspiratory and expiratory water traps.Conclusion: the breathing circuit water trap consists of a bowl and lid, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.Our user instructions that accompany the rt134 non-heated adult 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." the hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.
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