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Model Number BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L |
Device Problem
Material Too Soft/Flexible (4007)
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Patient Problem
Bradycardia (1751)
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Event Date 02/09/2022 |
Event Type
Injury
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Event Description
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The customer reported that the boxed pat circuit assy,3100a,fltrd,850l is extremely pliable/bendy which has implications with the flow on the oscillator and often stops the oscillator.It is often associated with the tubing that is connected to the humidifier.Tubing needed to be put back on/replaced and secured with a tape.It happened during use, and the patient became bradycardic and had to be manually ventilated.Also, lung derecruitment occurred.
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Manufacturer Narrative
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The customer sent a picture for evaluation however, the reported issue if the tube or component were soft or malleable was not confirmed.A sample is needed to perform a better investigation looking for any issue with the resin.Therefore the root cause was not determined.In addition pfmea 10a was reviewed and we have controls for this kind of issue.The issue occurred with three patients.Please refer to (b)(4) for the other two patients.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Search Alerts/Recalls
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