SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EXPANDABLE ANESTHESIA BREATHING CIRCUIT; 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
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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B3: month and year of event have been provided, day is unknown.D4: udi number 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 during a pre-use check, a leak alarm went off when installing the anesthesia machine.
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Manufacturer Narrative
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Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.Three device samples were received without its original packaging.Six photos were included for evaluation: photos show leaking in the component.Per visual inspection, it was not possible to detect any issue in the components assembled in the circuit.A leak test was performed, and a leak was detected during the test; the complaint was confirmed.Based on the analysis conducted the potential root cause of this issue is associated with the manufacturing process when the operator assembles the connector in the corrugated tube without due care, this causes a small crack between tube seal and the connector padlock.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The complaint fault has been escalated to address a full root cause investigation and is currently in the investigation phase.
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Search Alerts/Recalls
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