Model Number 10-85-00 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and replaced the hkr processor board to resolve the error.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The replaced board was requested for return 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 an s5 double head pump displayed an error message during priming.There was no patient involvement.
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Manufacturer Narrative
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The replaced hkr processor board was returned to livanova (b)(4) for further investigation.During evaluation of the returned device, the reported failure was reproduced.The root cause was determined to be errors in the internal memory bank in the micro-controller.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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Search Alerts/Recalls
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