VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY
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Model Number 3100A VENT,115V,60HZ,DOM |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2023 |
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.However, biomed was able to run the unit with no issues and it passes the circuit check and verification with no issues.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 problem with the 3100a ventilator during setup prior patient use where they could not get a good map (mean airway pressure).When the bias flow is at 12, they cannot get a map greater than 13.And when they try to go lower than a map of 10, the hfov (high frequency oscillatory ventilation) dumps all the pressure.Furthermore, there was no patient associated with the event.
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Search Alerts/Recalls
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