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Model Number BOXED PAT CIRCUIT ASSY, 3100A, FLTRD, 850L |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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The sample was not returned.Therefore, no root cause could be determined.The customer sent a picture however, we are unable to confirm if the tube or component were loose on their connection to have caused a leak between them, we need the physical sample for further investigation.The device history record was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured, inspected and released on 10june2021 per our internal procedures and no issues were found.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported that during ventilator use, the end user noticed a leak and traced it to the boxed pat circuit assy,3100a,fltrd,850l.It was on the inspired side after the humidifier.It was loose on the connector, allowing gas to escape.End user fixed the leak with a cable tie, and treatment was not interrupted.No harm is associated with the event.
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Search Alerts/Recalls
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