Model Number 16-02-85 |
Device Problem
Electrical Shorting (2926)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2022 |
Event Type
malfunction
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Event Description
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Livanova received a report that the electrical panel of the hospital started to alarm when there was an electrical overload; the source of this tripping was the heater-cooler system 3t device.There was no patient involvement.
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Manufacturer Narrative
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There was no patient involvement.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 heating elements on the patient side of the device were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The failure was traced back to defective heating elements.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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See initial report.
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Manufacturer Narrative
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The unit was serviced and it was found that the heating element from the patient side was causing the fault.Indeed, after replacing the patient heating element, no deviations were detected.Functional verification checks were performed and passed positively.The unit returned to service.A device service history review has been performed and identified that the unit was manufactured in 2014 and no other similar events have been reported.Based on the elements collected, the root cause has been traced back to a faulty heating element.No other specific action was currently deemed necessary.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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