Ps337622.Method: the complaint rt380 adult evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) in (b)(6) for investigation.Our investigation is therefore based on the information and video provided by the customer, and our knowledge of the product.Results: visual inspection of the provided video showed that the probe jacket was not attached to the inspiratory elbow of the complaint device.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.If any faults are detected the whole batch is placed on hold for investigation.The subject breathing circuit would have met the requirements at the time of production.The user instructions that accompany the rt380 breathing circuit state the following: check all connections are tight before use.Set appropriate ventilator alarms.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.
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A distributor in (b)(6) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the connector of a rt380 adult dual heated evaqua2 breathing circuit was found loose before patient use.There was no patient involvement.
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