SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number CA13E0/300/000JP |
Device Problems
Break (1069); Material Separation (1562); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: d4: lot number, udi section, expiration date, and h4: manufacture date are unknown, no information has been provided to date.G5: 510k is blank the device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that during the pre-use check, the gas sampling line connection is damaged.No patient injury or clinical affects was reported.
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Manufacturer Narrative
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Other, other text: d3, g1, and g2 email is: regulatory.Responses@icumed.Com.Device evaluation: 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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Search Alerts/Recalls
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