Model Number 10-80-00 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective power switch.The technician replaced the switch to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The power switch was requested back to livanova (b)(4) for further investigation.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 s5 roller pump power button did not power up the pump during setup.There was no patient involvement.
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Event Description
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See initial.
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Manufacturer Narrative
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The replaced switch was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be reproduced.The switch was found out of specification.Livanova deutschland notified the supplier about the reported issue and requested further actions to prevent recurrence.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Search Alerts/Recalls
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