(b)(4).Method: the complaint rt380 evaqua 2 adult breathing circuit was returned to fisher & paykel healthcare (f&p) for evaluation, where it was visually inspected and pressure tested.Our investigation is based on the information provided by the customer and our investigation of the returned device.Results: visual inspection of the returned complaint circuit was observed to have a small hole in the inspiratory limb.A pressure test revealed that the breathing circuit was out of specification.It was reported by the hospital that the circuit passed the ventilator leak test prior to set-up.Conclusion: we are unable to conclusively determine the cause of the breathing circuit to be out of specification.However, based on the information provided by the customer and our investigation, this likely occured during transport.All rt380 are designed to conform to iso:5367.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 reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death.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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