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
Defective Alarm (1014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2024 |
Event Type
malfunction
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Event Description
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It was reported to vyaire medical problem with 3100a ventilator where low and high alarms goes off at a lower than expected pressures.Furthermore, there was no patient harm reported associated with this event.
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Manufacturer Narrative
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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, vyaire received purchase order for a new alarm board.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Search Alerts/Recalls
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