Catalog Number 175050 |
Device Problem
Gas/Air Leak (2946)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/05/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn#: (b)(4).
|
|
Event Description
|
The complaint was reported as: "we have noticed an air leak in the supreme brand laryngeal mask.The doctor passed the supreme laryngeal mask no.4.0 and observed a leak due to not having been well connected, then the doctor passed the laryngeal mask no.5 and this one also showed a leak.At first, we believe it could be the patient's anatomy, but the same situation occurred the next day with another patient and another anesthetist.".
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
|
|
Event Description
|
The complaint was reported as: "we have noticed an air leak in the supreme brand laryngeal mask.The doctor passed the supreme laryngeal mask no.4.0 and observed a leak due to not having been well connected, then the doctor passed the laryngeal mask no.5 and this one also showed a leak.At first, we believe it could be the patient's anatomy, but the same situation occurred the next day with another patient and another anesthetist.".
|
|
Search Alerts/Recalls
|