NULL PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Lot Number 210608 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that during the pre-use check, leakage of air from the product was detected.No patient injury was reported.
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Manufacturer Narrative
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The breathing circuit and the hme filter were returned.Defective component (breathing circuit).Item number: c37101307j.Lot number: 4077822.Observation of the returned breathing circuit and the hme filter revealed no abnormalities such as damage related to the reported event.Next, we conducted a leak test on the breathing circuit and the hme filter, but no leaks were confirmed, and it was confirmed that the product conformed to the standard.Conclusion: the reported event was not confirmed.Root cause: the root cause was not identified dhr review was completed.
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