Model Number 16-02-85 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2022 |
Event Type
malfunction
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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 miami, florida.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a defective temperature probe.The part was replaced and the problem could be solved.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.
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Event Description
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Livanova received report that a heater cooler 3t gave an error code associated to discrepancy between measured temperatures between safety and control temperature sensors on the patient side during service.There was no patient injury.
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Manufacturer Narrative
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H.10: based on device history review, it can be highlighted that it was installed since 2011 and no other similar issue occurred.Based on available information and service activity results, the root cause of the reported issue can be traced back to an inaccurate measurement between the control and safety system due to a drifted sensor.
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Event Description
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See initial report.
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Search Alerts/Recalls
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