Model Number RT114 |
Device Problems
Gas/Air Leak (2946); Protective Measures Problem (3015)
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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 distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative, that two rt114 adult inspiratory heated breathing circuits failed the leak test before use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).The complaint rt114 adult inspiratory heated 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).The complaint rt114 adult inspiratory heated 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 distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative, that two rt114 adult inspiratory heated breathing circuits failed the leak test before use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt114 adult inspiratory heated breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected and pressure tested.Results: visual inspection of the complaint rt114 adult inspiratory heated breathing circuits revealed no damage found to any of the breathing circuits or the dryline.The pressure test also revealed that the breathing circuits were within specification.Conclusion: we were unable to determine what may have caused the failed leak test as reported by the customer, as no fault were found with the returned devices.All rt114 adult inspiratory heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt114 adult inspiratory heated 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." - "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 distributor in canada reported via a fisher & paykel healthcare (f&p) field representative, that two rt114 adult inspiratory heated breathing circuits failed the leak test before use.There was no patient involvement.
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Search Alerts/Recalls
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