Model Number RT380 |
Device Problems
Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt380 adult dual heated evaqua2 breathing circuits are currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
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Event Description
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A distributor reported on behalf of a healthcare facility in japan that six rt380 adult dual heated evaqua2 breathing circuits failed the pre-use leak test.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where they were visually inspected and pressure tested.Results: visual inspection revealed no damage or defect with the returned breathing circuits and drylines.Pressure testing revealed one of the returned breathing circuits was out of specification.A water bath test of this circuit identified a leak located at the connection of the inspiratory elbow and inspiratory tube.Conclusion: we were unable to determine the cause of the leak at the inspiratory elbow.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states 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." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
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Event Description
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A distributor reported on behalf of a healthcare facility in japan that six rt380 adult dual heated evaqua2 breathing circuits failed the pre-use leak test.There was no patient involvement.
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Search Alerts/Recalls
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