Model Number RT126 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt126 infant low flow breathing circuit is 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 reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a rt126 infant low flow breathing circuit failed the ventilator leak test before use.There was no patient involvement.
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Event Description
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A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a rt126 infant low flow breathing circuit failed the ventilator leak test before use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt126 infant low flow breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and leakage tested.Results: visual inspection of the returned rt126 infant low flow breathing circuit revealed no damage to the returned breathing circuit or the dryline.The leakage test also revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the leakage as reported by the customer, as no fault was found with the returned device.All rt126 infant low flow 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 rt126 infant low flow 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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Search Alerts/Recalls
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