NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number 492804-NL |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/18/2020 |
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.Product samples were received for evaluation.Visual and functional testing were performed.The samples were visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any damage on the units.No discrepancies detected.Sample was tested and the circuits passed the leak test.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.No root cause can be determined since the complaint was not confirmed.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 each time a circuit was put on a machine it leaked.No patient injury was reported.
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Search Alerts/Recalls
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