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 Type
malfunction
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Event Description
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A distributor reported on behalf of a healthcare facility in japan reported via a fisher & paykel healthcare (f&p) field representative that five 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).The complaint rt380 adult dual heated evaqua2 breathing circuit is 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 reported via a fisher & paykel healthcare (f&p) field representative that five 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 (b)(4) 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 pressure tested.Results: visual inspection revealed no damage or defect with the returned breathing circuit or the dryline.Pressure testing revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the reported event as there was no fault found with the returned device.All (b)(4) 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 (b)(4) 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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Search Alerts/Recalls
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