Model Number 25-40-45 |
Device Problem
Gas Output Problem (1266)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/15/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in bad (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
Livanova (b)(4) received a report that a s5 gas blender system displayed an error code associated to a discrepancy between the actual and the set value during priming.There was no patient involvement.
|
|
Event Description
|
See initial report.
|
|
Manufacturer Narrative
|
H10: the affected device was returned to the manufacturer site for repair.The reported error could not be reproduced.However, a deviation with the co2 valve was identified.The part has been replaced to solve the problem.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
|
|
Search Alerts/Recalls
|