Model Number RT380 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt380 circuit has recently been received at fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We are in the process to determine if f&p's product caused or contributed to the reported event.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 (b)(6) reported via a distributor that two rt380 adult dual heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.There was no patient involvement.
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Event Description
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A healthcare facility in japan reported via a distributor that two rt380 adult dual heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: two complaint rt380 adult evaqua 2 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 to the returned breathing circuits or dryline.The pressure test revealed that the both subject breathing circuits were within specification.Conclusion: we were unable to determine what may have caused the leak as reported by the customer as no fault was found with the returned devices.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject 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: - "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." - "set appropriate ventilator alarms.'.
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Search Alerts/Recalls
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