Model Number 16-02-82 |
Device Problems
Device Sensing Problem (2917); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/12/2020 |
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 review of the dhr could not identify any deviations or nonconformities relevant to the issue.A livanova field service representative was dispatched to the facility to investigate the device and found out also that the device was warming only between 31 and 32 degrees.The temperature sensors were replaced and the heaters placed on order to complete the repair.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 displayed an error code on the patient side associated to a too high temperature difference of the temperature sensors in the control/safety system during procedure.There was no report of patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H10: the issue was solved by the replacement of the temperature sensor.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Search Alerts/Recalls
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