Model Number RT265 |
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 11/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint (b)(6) infant dual-heated (b)(6) 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 healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that ten (b)(4) infant dual-heated (b)(4) breathing circuits failed the leak test before use.There was no patient involvement.
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Event Description
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A healthcare facility in arkansas reported via a fisher & paykel healthcare (f&p) field representative, that ten rt265 infant dual-heated evaqua2 breathing circuits failed the leak test before use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected and pressure tested.Results: visual inspection of the complaint rt265 infant dual-heated evaqua2 breathing circuits revealed no damage found to any of the breathing circuits or the dryline.The pressure test also revealed that the breathing circuits were within specification.Conclusion: we were unable to determine what may have caused the failed leak test as reported by the customer, as no fault were found with the returned devices.However, the leak the customer experienced were most likely due to a loose connection in the setup.All rt265 infant 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 rt265 infant dual-heated 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." "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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