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 04/12/2022 |
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 our investigation.
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Event Description
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A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that two rt380 adult dual heated evaqua2 breathing circuits failed the pre-use leak test.There was no reported patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a rt380 adult dual heated evaqua2 breathing circuit failed the pre-use leak test.Conclusion: without the return of the complaint device, we are unable to determine the cause of 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.The subject infant 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 healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that two rt380 adult dual heated evaqua2 breathing circuits failed the pre-use leak test.There was no reported patient involvement.
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Search Alerts/Recalls
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