SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C45101796D-NL |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: d4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank device is exempt.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Event Description
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It was reported that the customer was getting "frequent leak or compliance failures during the automatic leak test of the machines".Discovered prior to patient use.There was no patient or clinical injury and the reported outcome was resolved.
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Search Alerts/Recalls
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