(b)(4).Method: the four complaint rt134 breathing circuits were visually inspected, pressure tested and immersed in a water bath to test for leaks.Results: pressure testing revealed that the circuits were out of specification.The water bath test revealed leaks between the water trap bowls and the lids.A lot check revealed no other similar complaints for lot number 130514 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 condensate.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 customer had commented that the complaint circuits passed the ventilator leak test which suggests that the water traps became loose during setup of the devices.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.
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