VYAIRE MEDICAL OY 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY
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Model Number 3100A VENT,115V,60HZ,DOM |
Device Problem
Low Readings (2460)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file indentification: (b)(4).H3: 81 other ¿ currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.No patient involvement.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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It was reported to vyaire medical the 3100a will power on, but will not start oscillating, the start/stop switch is not functioning.No patient involved.
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Search Alerts/Recalls
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