Model Number RT266 |
Device Problems
Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Output Problem (3005)
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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 healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative, that the dryline of ten rt266 infant dual-heated evaqua2 breathing circuits were found with incorrect connectors.On 29 november 2021, an investigation was completed indicating that the malfunction would result in a leak.There was no patient involvement.
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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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Manufacturer Narrative
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(b)(4).Method: the complaint (b)(4) infant dual-heated evaqua2 breathing circuits were not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the provided photograph of the complaint (b)(4) infant dual-heated evaqua2 breathing circuits revealed the incorrect connectors were found assembled to the ventilator side of the dryline.Conclusion: the connectors were 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 (b)(4) 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: "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 oregon reported via a fisher and paykel healthcare (f&p) field representative, that the dryline of ten rt266 infant dual-heated evaqua2 breathing circuits were found with incorrect connectors.On 29 november 2021, an investigation was completed indicating that the malfunction would result in a leak.There was no patient involvement.
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Search Alerts/Recalls
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