Model Number 16-02-85 |
Device Problems
Complete Loss of Power (4015); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in canton, ohio.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Ac mains board was replaced since most likely was the cause of the issue.Subsequent functional verification testing was completed without no 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.
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t device shut off and displayed an error message during a procedure.The user was able to shut off and on twice the unit and to continue the case.There was no patient injury.
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Manufacturer Narrative
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Complaints database analysis revealed no similar event since unit installation in 2015.Based on the information available and the service activity performed by technician, it cannot be ruled out that the most likely root cause was an intermittent failure of the ac main board.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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