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Model Number 3100A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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 to vyaire medical that the 3100a when you physically touch the unit the pressure drops.Customer stated there are no parameters being changed when this occurs, its only when you touch the unit.At this time, there is no information about patient involvement.
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Search Alerts/Recalls
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