Model Number 16-02-80 |
Device Problem
Temperature Problem (3022)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/25/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a defective stirrer motor and processor board.Parts were replaced and problem solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
|
|
Event Description
|
Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message associated to the stirrer motor after a procedure.There was no report of patient injury.
|
|
Manufacturer Narrative
|
H10: the most likely root cause of the reported issue is traceable to environmental condition in which the pump worked.Water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase led to pump bearing corrosion causing the reported failure.
|
|
Event Description
|
See initial report.
|
|
Search Alerts/Recalls
|