VYAIRE MEDICAL INC. HUMIDIFICATION CHAMBER, 10/CS; 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 03/04/2023 |
Event Type
Injury
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Event Description
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It was reported to vyaire medical that water was observed to be dripping from the sealant edge of humidification chamber, 10/cs where it meets the metal plate.The water was found pooled on the floor, surrounding the high flow machine, electrical heater wire and circuit.The staff felt as the humidification bag filled with water and expanded, it caused pressure on the humidification chamber.The patients involved were neonatal patients ¿babies of various gestation and age/weight.All preterm babies requiring respiratory high flow support (hft)¿.They were not harmed since the faulty chambers were removed.
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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) 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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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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