Model Number RT200 |
Device Problems
Leak/Splash (1354); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The rt200 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 distributor reported on behalf of a healthcare facility in china that the tubing of a rt200 adult dual heated breathing circuit was found leaking before patient use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).The rt200 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.Results: the customer reported that the tubing of a rt200 adult dual heated breathing circuit was found leaking before patient use.Conclusion: without the complaint device, we are unable to 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.".
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Event Description
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A distributor reported on behalf of a healthcare facility in china that the tubing of a rt200 adult dual heated breathing circuit was found leaking before patient use.There was no patient involvement.
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Search Alerts/Recalls
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