SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C49101320J |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other, other text: b3: month and year of event have been provided, day is unknown.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.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 a leak alarm occurred and use was discontinued.When another circuit was installed, it could be used it without any problems.Patient involvement unknown.
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Manufacturer Narrative
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H3, h6: event methods, evaluation, and conclusion codes: updated.One device was received for investigation.During visual inspection, no damage or anomalies were observed with the device.The device was functionally tested, and no leakage was observed from the sample device.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information, the investigation could not confirm the reported complaint or assign a root cause.No actions have been assigned at this time.
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Search Alerts/Recalls
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