VYAIRE MEDICAL INC. VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Model Number ANES CIRCUIT, ADULT, 60 IN CORR, 3L BAG |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2023 |
Event Type
malfunction
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Event Description
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It was reported to vyaire medical that anes circuit, adult, 60 in corr, 3l bag had a leak during patient use.Furthermore, the customer confirmed no harm was done to the patient.
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Manufacturer Narrative
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H3: 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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Manufacturer Narrative
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Result of investigation: the suspect device was not returned for evaluation.The reported lot number was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured, inspected and no issues were found.No samples were returned and was unable to further investigate the complaint.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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