Model Number CONNECTOR OMNIFLEX 50/CS |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2022 |
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.Therefore, root cause has not 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 to vyaire medical that the connector omniflex 50/cs doesn't fit securely on the tracheal tube.The said issue occurred during patient use.Furthermore, there was no harm done to the patient.
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Manufacturer Narrative
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Result of investigation: the customer did not send pictures or the physical sample for investigation.We require the physical sample and/or pictures to perform a better investigation looking for the possible cause of the reported defect.The device history record for the fg part number 3222 was reviewed and there were no issues during the product manufacture.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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