Model Number CANNULA CUSHION INFANT W/7FT TB 50/CS |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.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 the cannula cushion infant w/7ft tb 50/cs experienced lack of flow.The customer confirmed that there was no patient harm associated with the reported event.
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Manufacturer Narrative
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Result of investigation: picture and sample were provided and evaluated.Performed visual and functional tests and no issues were found.Therefore the defect reported by the customer was not confirmed.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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