NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number CA24B0/400/000JP |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected at a distance of 12" under normal lighting to received units, in order to detect any damage on the unit.The breathing bag has a hole.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.All procedures are being carried appropriate.The most probable root cause is that the production personnel did not detect and scraped the damaged breathing bag.Production personnel was trained to detect any marks or damage on the breathing bags.Udi is unknown.Operator of device is unknown.Manufacturing site address is unknown.Pma/510k is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that during a pre-use check, the customer noticed that air was leaking from a pinhole in the product.No patient injury was reported.
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Search Alerts/Recalls
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