Model Number RT228 |
Device Problems
Complete Blockage (1094); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The rt228 infant breathing circuit is not sold in the usa but is similar to a device that is sold in the usa.The 510(k) for the similar device is k020332.We are currently in the process of fnalising our investigation.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 (b)(6), via a fisher & paykel healthcare (f&p) field representative that a rt228 infant breathing circuit restrictor was blocked.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 rt228 infant breathing circuit restrictor was blocked.There was no patient involvement.
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Manufacturer Narrative
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Ps373802, the rt228 infant breathing circuit is not sold in the usa but is similar to a device that is sold in the usa.The 510(k) for the similar device is k020332.Method: the complaint rt228 infant breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected.Results: visual inspection of the returned sle adaptor could not identify any fault that resulted in the reported occlusion.Conclusion: we are unable to determine the cause of the reported event as no fault was found with the returned device.The sle restrictors of the rt228 infant breathing circuits are sampled and visually inspected during production.All infant breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt228 infant breathing circuit state the following: check all connections are tight before use.Ensure appropriate venitlator or flow source alarms are set before connecting breathing set to patient.Perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient.Appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in serious harm or death.
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Search Alerts/Recalls
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