Model Number RT265 |
Device Problems
Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt265 infant dual heated evaqua2 breathing circuits are currently en route to fisher & 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 rt265 infant dual heated evaqua2 breathing circuit pops off during device set up.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: six pressure lines of rt265 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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Event Description
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A healthcare facility in netherlands reported via a fisher & paykel healthcare field representative that the pressure line of an rt265 infant dual heated evaqua2 breathing circuit pops off during device set up.There was no patient involvement.
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Search Alerts/Recalls
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