(b)(4).Method: the returned complaint rt134 breathing circuit was visually inspected, pressure tested and immersed in a water bath to check for leak.Results: pressure testing revealed that the circuit was out of specification.The water bath test revealed that the leak was in the expiratory water trap.A lot check revealed no other complaints for lot number 130923.Conclusion: the water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be disconnected during use for draining water.The water trap leak was located at the seal between the water trap bowl and the water trap lid.All circuits are pressure tested for leaks during production and those that fail are rejected.This suggests any leak must have developed post production during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt134 adult breathing circuit state the following: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.Hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.
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