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Model Number AVEA |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3: 81 other - 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.Device not returned yet.
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Event Description
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It was reported to vyaire medical that the avea ventilator lost connectivity to the vvs server.Loss of data to rkp & emr.The loss of connectivity was persistent (lantronix gateway did not recover as expected).This event happened during patient use.There was no patient injury was caused by the event, or any patient care affected.
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Search Alerts/Recalls
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