Model Number 16-02-85 |
Device Problem
Electrical Power Problem (2925)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/21/2021 |
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 (b)(4).The incident occurred in (b)(6).The technician in charge of the maintenance traced the fault back to a defective power supply.The part was replaced and the problem solved.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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Livanova (b)(4) received a report of a heater-cooler system (b)(4) power failure during maintenance.There was no patient involvement.
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Manufacturer Narrative
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Reportability decision changed to not reportable event since, through follow up communication, livanova learned that the reported error was on cardioplegia side which is not likely to result in death or serious injury.
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Event Description
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See initial report.
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Search Alerts/Recalls
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