Model Number 3100A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
Event Type
malfunction
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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.H3 other text : device not returned yet.
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Event Description
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It was reported to vyaire medical that the 3100a ventilator control knob (green) is not allowing them to adjust the map (mean airway pressure).The customer confirmed that there is no patient involvement associated with this reported event.
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Manufacturer Narrative
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Result of investigation: vyaire field service went onsite found unit has a faulty needle valve.As a resolution, needle valve assembly was replaced and tested the unit to confirm unit is working properly.Unit is ready for patient used.
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Search Alerts/Recalls
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