Model Number RT380 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2023 |
Event Type
malfunction
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Event Description
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A distributor reported on behalf of a healthcare facility in china that a rt380 adult dual-heated evaqua2 breathing circuit failed the ventilator leak test before use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and leak tested.Results: visual inspection revealed no damage or defect with the returned breathing circuit.Leak testing revealed that the dryline was outside of specification.Conclusion: we were unable to determine what may have caused the reported event.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.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 china that a rt380 adult dual-heated evaqua2 breathing circuit failed the ventilator leak test before use.There was no patient involvement.
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Search Alerts/Recalls
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