Model Number RT266 |
Device Problems
Leak/Splash (1354); Misassembled During Installation (4049)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt266 infant 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 investigation.
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Event Description
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A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative, that the dryline of twenty rt266 infant dual-heated evaqua2 breathing circuits were found with incorrect connectors resulting to air leakage.There was no patient involvement.
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Manufacturer Narrative
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Ps(b)(4).Method: the complaint rt266 infant dual-heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected.Results: visual inspection of the complaint rt266 infant dual-heated evaqua2 breathing circuits revealed the incorrect connectors were found assembled to the ventilator side of the dryline.Conclusion: the connector was incorrectly assembled during production.An incorrectly assembled circuit would be detected prior to use on a patient, either during set up (cannot connect) or during the pre-functional set up tests (fails leak and pressure test).Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit state "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient".Our user instructions also state the following: - "check all connections are tight before use." - "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." - "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 california reported via a fisher and paykel healthcare (f&p) field representative, that the dryline of twenty rt266 infant dual-heated evaqua2 breathing circuits were found with incorrect connectors resulting to air leakage.There was no patient involvement.
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Search Alerts/Recalls
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