Model Number RT265 |
Device Problem
Pressure Problem (3012)
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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 rt265 infant dual-heated evaqua2 breathing circuits have recently been received at fisher & paykel healthcare(b)(4) for evaluation.We will provide a follow up report upon completion of our 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 two rt265 infant dual-heated evaqua2 breathing circuits had pressure issues while in use on a patient.The patient was provided alternative therapy using a rd900 neopuff infant resuscitator while the circuit and ventilator were replaced.The delivered fio2 was increased from 40% to 55%.No further patient consequences were reported.
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Event Description
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A healthcare facility in united kingdom reported via a fisher & paykel healthcare (f&p) field representative, that the rt265 infant dual-heated evaqua2 breathing circuit had pressure issues while in use on a patient.The patient was provided alternative therapy using a rd900 neopuff infant resuscitator while the circuit and ventilator were replaced.The delivered fio2 was increased from 40% to 55%.No further patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Method: three rt265 infant dual-heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand for investigation.We are unable to confirm the rt265 circuit in use at the time of the reported incident.The three circuits were visually inspected and pressure tested.Results: visual inspection of the circuits revealed no visible damage to the three circuits or the dryline.Devices 1 and 3 were pressure tested and were found to be within specification.Pressure testing of device 2 indicated that the breathing circuit was outside of specification.Additional testing of the device revealed a leak at the seal between the swivel top and bottom.Conclusion: we were unable to determine the cause of the swivel leak.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 circuit 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." - "set appropriate ventilator alarms.".
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Search Alerts/Recalls
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