VYAIRE MEDICAL, INC PALM SPRINGS 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY
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Model Number 3100A VENT,115V,60HZ,DOM |
Device Problem
High Readings (2459)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
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 : troubleshooting was requested.
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Event Description
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It was reported to vyaire medical that during a pre-use check on the unit it was noticed that when the stopper is taken out of the circuit, the map will only drop to 2.0cm.It will not go down to zero with adjusting the zero pot on the alarm board.No patient involvement was reported.
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