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 12/20/2023 |
Event Type
malfunction
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Event Description
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It was reported to vyaire medical that the 3100a ventilator cannot hold pressure.Furthermore, there was no patient associated with the reported event.
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).H3: 81 other the customer reported that they will not return the defective unit/part for evaluation.Therefore, no root cause could be determined.However, customer indicated that the end user's circuit is still connected to the vent.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device will not be returned.
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