SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
|
Back to Search Results |
|
Catalog Number C45101340-NLJ |
Device Problem
Gas/Air Leak (2946)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/12/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during pre-use testing an air leak was found.No harm or adverse effects reported.
|
|
Manufacturer Narrative
|
Other, other text: d4: udi section is blank, 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.
|
|
Manufacturer Narrative
|
G1,2 email is: regulatory.Responses@icumed.Com.Two photos were included for evaluation.One device was received without the original package.Per visual inspection, it was not possible to detect any issue which could cause the leaking failure mode.Per functional testing, the leaking issue was not detected in the leak test; complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken since the customer was not confirmed.
|
|
Search Alerts/Recalls
|
|
|