Model Number RT200 |
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 12/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Section g4: the rt200 adult dual heated 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.Section h10: the subject rt200 adult dual heated breathing circuit has been requested to be returned to nz for evaluation.We will provide a follow up report on completion of our investigation.
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Event Description
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A distributor reported on behalf of a healthcare facility in china that a rt200 adult dual heated 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).Section g4: the rt200 adult dual heated 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 rt200 adult dual heated breathing circuit was 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.The customer also reported that they had examined the subject circuit and did not identify any damage.Results: the customer reported that the rt200 adult dual heated breathing circuit failed the leak test before patient use.Conclusion: without the complaint device, we are unable to confirm the fault or determine what may have caused the reported event.All rt200 adult dual heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt200 adult dual heated breathing circuit show in pictorial format the correct set-up of the circuit and also states 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." - "visually inspect beathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged.".
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Event Description
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A distributor reported on behalf of a healthcare facility in china that a rt200 adult dual heated breathing circuit failed the ventilator leak test before use.There was no patient involvement.
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Search Alerts/Recalls
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