(b)(4).The rt268 infant evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.Method: the complaint rt268 infant evaqua2 breathing circuit was returned to fisher & paykel healthcare (b)(4) where it was visually inspected.Our investigation is also based on our knowledge of the product and previous similar complaints from this particular customer.Results: visual inspection revealed that the evaqua2 tubing had degraded near the patient end connector.Conclusion: we were unable to conclusively determine what may have caused the evaqua2 tubing to degrade.However we are aware of previous similar complaints from the customer, in which breathing circuits came into contact with tyloxapol and were used longer than the intended period of 7 days.All rt268 infant dual heated evaqua2 breathing circuits 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.Our user instructions that accompany the rt268 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." - "this product is intended to be used for a maximum of 7 days." - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure.".
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