Model Number RT268 |
Device Problems
Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975); Device Fell (4014)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k034026.The complaint rt268 infant dual-heated evaqua2 breathing circuit is currently en route to fishser & paykel healthcare in (b)(4) for evaluation to determine if it had a malfunction, which could have caused or contributed to the reported event.We will provide a follow-up report once we have completed our investigation.
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Event Description
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A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the pressure line of an rt268 infant evaqua2 breathing circuit falls off during setup.There was no patient involvement.
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Event Description
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A healthcare facility in japan reported via a fisher & paykel healthcare field representative that the pressure line of an rt268 infant evaqua2 breathing circuit falls off during setup.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k034026.Method: six pressure lines of rt268 infant dual heated evaqua2 breathing circuit were received at fisher & paykel healthcare in new zealand for evaluation and were visually inspected.Results: visual inspection of pressure lines revealed that a moulding defect was found on the elbow of pressure lines.Conclusion: we were unable to determine what caused the moulding defect of the pressure line elbow.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit states: "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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