Model Number 16-02-85 |
Device Problems
Device Alarm System (1012); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no known patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in united states.Livanova initiated an investigation.Livanova service engineer found the circulation motor not working and also the distribution board was not working and the cpu board was not working.Replaced all three components on system to repair the problem.Tested and put back into 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 received a report about heater cooler error message on patient side.No patient involvement reported.
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Manufacturer Narrative
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Medical device problem code and component code have been updated since the codes included in the initial report were incorrect.Manufacturing date of the device has been added to the dedicated h.4 section.Customer information has been updated in the dedicated e section.H.10: the most likely root cause was a stirrer motor circuit board electronic fault.This led to the defect on the safety resistors on the distribution board and on the process board.
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Event Description
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See initial report.
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Search Alerts/Recalls
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