Model Number 28-95-85 |
Device Problem
Failure to Auto Stop (2938)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
There was no patient involvement.Livanova (b)(4) manufactures the s5 control panel mrp 85.The incident occurred in (b)(6).The customer called livanova technical service to inform that the reported issue re-occurred.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The control panel of the slave pump was replaced.No issues presenting after replacement.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 the stop-link function did not work on two pumps used on a s5 system during a procedure.In details, the "slave" pump (s5 control panel mrp 85) did not stop when the arterial pump stopped.Reportedly, the symbol of the stop-link function activated was not displayed confirming that the pumps were not engaged.Powering off the controller and turning it back on improved the issue.This is a re-occurrence of an already reported event.There was no report of patient injury.
|
|
Manufacturer Narrative
|
H.10: the most likely root cause of the reported event is an intermittent power supply to the processor board due to a faulty can cable of the pump control panel.
|
|
Event Description
|
See initial report.
|
|
Search Alerts/Recalls
|