(b)(4).Method: the complaint rt380 breathing circuit was returned to fisher & paykel healthcare (b)(4) for inspection.The complaint device was pressure tested and submerged in a water bath to check for leaks.Result: the pressure test revealed that the complaint device did not perform within the required specification.The water bath test revealed that the leak was located at the elbow connector of the circuit's expiratory limb.Conclusion: we were unable determine the cause of the reported fault.However, it must be noted that we have not received a complaint of similar nature since 2013.All rt380 breathing circuits are pressure tested for leaks during production and those that fail these tests are rejected.This suggests that the leak developed after the complaint device was released for distribution.The user instructions that accompany the rt380 breathing circuit state: do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.The user followed our user instructions correctly as the hospital found the leak during the ventilator leak test.
|