Model Number 16-02-85 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/29/2020 |
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 (b)(6).A livanova field service representative was dispatched to the facility to investigate the device but the reported issue could not be reproduced.The technician decided to re-calibrate the temperature sensor.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 (b)(4) received a report that a heater-cooler system 3t was not heating on the patient side during priming.There was no patient involvement.
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Manufacturer Narrative
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H.10: based on troubleshooting results, the most likely root cause of the reported event is temperature sensors calibration that drifted over time.
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Event Description
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See initial report.
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Search Alerts/Recalls
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