Model Number 16-02-80 |
Device Problem
Unexpected Shutdown (4019)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/25/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The mains cable was found to be damaged.No visual defect was identified, however when the mains cable is wiggled the unit powered on/off.To cure this fault 12" of mains cable was removed.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 of a heater-cooler system 3t powering down after few seconds being powered on.The customer reported that when the device was tested, the cable and mains lead were warm and the device remained powered on.There was no patient involvement.
|
|
Manufacturer Narrative
|
No similar event has been recorded on the device since its installation in 2019 by reviewing the complaints database.The mains cable damage can lead to conductor strand breakage, thus, it cannot be ruled out that the sudden shutdown of the device is related to an interrupted current flow due to damage in the mains cable segment near the plug.
|
|
Search Alerts/Recalls
|