(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Our investigation is based on the information and photographs provided by the hospital.Results: the photographs showed scratches and pinholes on the surface of the inspiratory limb.Conclusion: without the complaint device, we were unable to determine what had caused the leaking on the inspiratory limb.However, it was noted that the subject breathing circuit was used on a patient for a month.All rt266 infant dual heated evaqua2 breathing circuit are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Moreover, the hospital reported that the damage occurred after a period of use, which suggests that the observed leaking happened after the subject rt266 infant breathing circuit was released for distribution.Our user instructions that accompany the rt266 infant 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 alarms.".
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