Model Number RT319 |
Device Problem
Obstruction of Flow (2423)
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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 rt319 adult bi-level cpap breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.We are currently in the process of completing our investigation.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 the uk reported, via a fisher & paykel healthcare field representative, that the exhalation port of a rt319 adult bi-level cpap breathing circuit was found occluded by patient secretions during use.There was no reported patient consequence.
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Manufacturer Narrative
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(b)(4).The rt319 adult bi-level cpap breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt319 bi-level/cpap breathing circuit and rt017 exhalation port were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the exhalation port of a rt319 adult bi-level cpap breathing circuit was found occluded by patient secretions during use.Conclusion: without the return of the complaint devices, we are unable to determine what may have caused the reported event.A recurring pin gauge test and visual inspection is conducted on the rt017 exhalation port to ensure there are no occlusions in the exhalation holes prior to release for distribution.The subject rt017 exhalation port would have met the required specification at the time of production.The user instructions that accompany the rt319 adult bi-level/cpap inspiratory-heated breathing circuit include the following warnings: - when using the exhalation port, it should not be used on patients who have copious secretions, at risk of nausea/vomiting, or at high risk of aspiration of emesis.If symptoms of these conditions occur, discontinue treatment immediately.- check for occlusions in both inspiratory and pressure line before connecting to patient.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.- do not block or seal the vent holes on the exhalation port.- 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 healthcare facility in the uk reported, via a fisher & paykel healthcare field representative, that the exhalation port of a rt319 adult bi-level cpap breathing circuit was found occluded by patient secretions during use.There was no reported patient consequence.
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Search Alerts/Recalls
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