NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number CA17K0/000/004JP |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
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 observed.The product was further checked and a pinhole in it was found.No patient involvement.No additional information.
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Manufacturer Narrative
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Two units were returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source was to be found with the supplier.Corrective actions were implemented through supply investigation (b)(6).Personal notification to ensure that all tanks are being screened to prevent any air and possible surface imperfection that are created by agitation of the tanks.Dhr review was done, no issues related to the original complaint were found.
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Search Alerts/Recalls
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