Catalog Number 150040 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/09/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that:.Places laryngeal mask '4 where there is a leak in the anaesthesia machine, the balloon is inflated and after a while it deflates.The reported defect was detected prior to use (in a clinical setting).There was no patient involvement.
|
|
Event Description
|
It was reported that:.Places laryngeal mask '4 where there is a leak in the anaesthesia machine, the balloon is inflated and after a while it deflates.The reported defect was detected prior to use (in a clinical setting).There was no patient involvement.
|
|
Manufacturer Narrative
|
(b)(4).The manufacturer reported: "the returned complaint sample was unpacked and unloaded from the original packaging upon receipt.Its product pouch was not returned.Record card also not available.Since functional test was conducted to actual complaint received, and no abnormalities found related to cuff leak.This complaint was identifying as non-manufacturing related (no problem found on sample)." teleflex will continue to monitor and trend for reports of this nature.
|
|
Search Alerts/Recalls
|