Model Number 16-02-95 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Event Description
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Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error code during procedure.Therefore, the customer switched to another device.After the procedure was completed, the customer tried to reproduce the error, but the error did not recur.There was no report of patient injury.
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Manufacturer Narrative
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There was no patient involvement.The heater-cooler 16-02-95 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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H.10: a livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The temperature sensor have been calibrated as precaution.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the error reported by the customer remains unknown since the customer did not remember the code and no error could be reproduced during service activity.No additional information is available on this specific case and no further investigation is possible.Thus, the root cause could not be determined.No further complaint on this unit/ issue has been received up to date thus it is reasonable to assume that the error was temporary and did not recur.
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Event Description
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See initial report.
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Search Alerts/Recalls
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