Model Number 16-02-85 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2021 |
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 and replaced the complete patient bridge.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 of a heater-cooler system 3t taking more time than usual to reach the set high temperature on the patient side during procedure.There was no report of patient injury.
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Manufacturer Narrative
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H10: an inspection of the bridge revealed that one of patient pump was noisy.Investigation is still ongoing.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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See initial report.
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Manufacturer Narrative
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H10: the reported issue was most likely due to a decrease in pumping capacity leading the patient pump to not work properly.
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Event Description
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See initial report.
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Search Alerts/Recalls
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