Model Number RT268 |
Device Problems
Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.We are currently in the process of obtaining additional information from the customer for evaluation.We will provide a follow-up report upon completion of our investigation.
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Event Description
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A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the rt268 infant dual-heated evaqua2 breathing circuit did not pass the ventilator test during use.There was no reported patient consequence.
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Event Description
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A distributor in colombia reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the rt268 infant dual-heated evaqua2 breathing circuit did not pass the ventilator test.There was no reported patient consequence.
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Manufacturer Narrative
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Ps362455 the rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.Section b5 was corrected.Method: the complaint rt268 infant dual-heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the rt268 infant dual-heated evaqua2 breathing circuit did not pass the ventilator test.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt268 infant dual-heated evaqua2 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 rt268 infant dual-heated evaqua2 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." - "set appropriate ventilator alarms.".
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Search Alerts/Recalls
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