VYAIRE MEDICAL INC. AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number HUMIDIFICATION CHAMBER, 10/CS |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
Injury
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Event Description
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It was reported to vyaire medical that water was noted to be dripping from the sealant edge of the airlife¿ autofill humidification chamber where it meets the metal plate.Water was found to be pooled on the floor, surrounding the high flow machine.The electrical heater wire and circuit appeared wet.The machine squealed with a loud noise.End users felt that as the humidification bag filled with water and expanded, it caused pressure on the humidification chamber.It happened during patient use.Interventions included replacement of the humidification chamber/circuit and immediate removal of the high flow machine for checking of machine and heater wires.No fault of damage to machine or heater wires reported.The patient remained stable.No harm reported.
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.The issue occurred with four patients.Please see (b)(4), (b)(4), and (b)(4) for the rest.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Manufacturer Narrative
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Additional information: g3, g6, h2, h3, h6 and h10 result of investigation: vyaire medical was not able to verify the reported issue.Vyaire believe that water leakage occurs because the maximum operating pressure is generated in the use process, and the staff will cause the air to reverse pour into the water bag under this pressure, resulting in the expansion of the water bag.However, in this complaint, no further investigation was performed as the product was lost while in transit.Therefore, a definitive root cause could not be determined, and corrective or preventive action is not indicated at this time.
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