Model Number IPN922811 |
Device Problem
Gas/Air Leak (2946)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/14/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn#(b)(4).
|
|
Event Description
|
It was reported that "air leaked from the device during use on a patient.Therefore, it was replaced with a new unit".Specific information regarding the leak was not available.No patient harm or injury reported.Patient condition reported as "fine".
|
|
Manufacturer Narrative
|
(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "complaint sample was received.No original product pouch was returned along with the complaint sample.The label print on the airway tube showed size 4 on the return lma supreme sample as per reported.Leak test was performed to the complaint sample.Presence of bubbles at joint between inflation balloon to check valve was observed.Visual inspection focusing on joining area (leakage) on current production lot (lma supreme): lot 11c22c0887 was performed.There was no abnormality was found.Dhr was reviewed.No abnormality was found." the complaint has been confirmed.The manufacturing site has determined that the root cause is manufacturing related.A non-conformance was opened to address this issue.
|
|
Event Description
|
It was reported that "air leaked from the device during use on a patient.Therefore, it was replaced with a new unit".Specific information regarding the leak was not available.No patient harm or injury reported.Patient condition reported as "fine".
|
|
Search Alerts/Recalls
|