(b)(4).Due to middle east respiratory syndrome (mers) cases in south korea and the potential risk of infection,the complaint rt385 breathing circuit was not returned to fisher & paykel healthcare in (b)(4) for investigation.It was destroyed in south korea.Our analysis is accordingly based on the information provided by the hospital staff and our knowledge of the product.Without the complaint device, we were unable to determine definitively the root cause of the fault reported by the hospital staff.However, based on the results of our previous investigations on similar complaints, the reported leak is most likely due to a loose connection.All rt385 adult dual heated evaqua2 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.The subject rt385 adult breathing circuit would have met the required specification at the time of production.Our user instructions that accompany the rt385 adult dual heated evaqua2 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 alarm.".
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