SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C37101329-NLJ |
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 03/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Month and year of event have been provided, day is unknown.D4: udi section is unknown, no information provided to date.G5 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 required.
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Event Description
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It was reported that during the use of the product, an air leak alarm went off.After the customer changed the item to another new one, the event was settled.No patient injury reported.It has been reported that no additional information will available for this event.
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Manufacturer Narrative
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Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received in used condition without original packaging.The device was visually inspected without magnification at a distance of 12 to 16 inches and normal conditions of illumination no observations were detected.A leak test was performed in which the device passed.The complaint was not confirmed no other analysis was performed.A device history record (dhr) review showed there were no issues or non-conformances were reported during the manufacturing of the reported lot number.No actions taken as complaint was not confirmed.
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Search Alerts/Recalls
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