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Model Number LTV 1200 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2021 |
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 laptop ventilator 1200 delivered vt(tidal volume) exceeds high limit.It was measured 560 ml to high.At this time, there is no information regarding patient involvement associated with the reported event.
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Search Alerts/Recalls
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