(b)(4).Method: the complaint rt380 evaqua 2 adult breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, and our knowledge of the product.Results visual inspection of the provided photograph revealed that the tube of a rt380 adult dual heated evaqua2 breathing circuit inspiratory limb was found with cut.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit state the following: "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.".
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