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
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Event Description
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It was reported to vyaire medical problem with 3100a ventilator where the device piston stopped while on a patient.Furthermore, there was no patient harm reported associated with the event.
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Manufacturer Narrative
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H3: 81 other - the suspect device has not been returned for evaluation.Therefore, root cause has not been determined.However, the customer confirmed that after changing the patient circuit, the issue was resolved.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned.
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