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Model Number AVEA |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).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 was received.
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Event Description
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The customer reported that the user interface module is intermittently powering up on avea ventilator.At this time, patient involvement associated with the reported event is unknown.
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Search Alerts/Recalls
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