(b)(4), method: the complaint rt139 bi-level/cpap circuits were returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: visual inspection of the returned rt139 bi-level/cpap circuits revealed that the elbow connector was partially detached and the patient end connector was fully attached.There were no signs of damage to the connectors or tubing of the returned breathing circuits.Conclusion: we are unable to determine what may have caused the partial disconnection of the elbow connector.All rt139 bi-level/cpap circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt139 bi-level/cpap circuit state the following: "check all connections are tight before use." "before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed.".
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