Model Number 3100A |
Device Problem
Failure to Cycle (1142)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Event Description
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It was reported to vyaire medical that the 3100a ventilator oscillator stopped when rt (respiratory therapist) was setting up.The customer confirmed that there is no patient involvement associated with this reported event.
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).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.
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Manufacturer Narrative
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Result of investigation: vyaire field service went onsite unit passed circuit test and performance checks, unit run for 30 minutes without any issue.As a resolution, thumb wheel switch and alarm board were replaced.Change thumb wheel settings without unit shutting down.Passed circuit test and performance checks.Unit returned to customer and cleared for clinical use.
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Search Alerts/Recalls
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