Model Number 10-80-00 |
Device Problems
No Display/Image (1183); Loss of Power (1475)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/17/2018 |
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)(6).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 faulty processor board.The technician replaced the board to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The board has been requested for return to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 roller pump display lost power during maintenance.There was no patient involvement.
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Manufacturer Narrative
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During the investigation of the processor board the reported issue could be reproduced.Evaluation of the serial read out of the pump memory showed internal firmware bugs in the microcontroller.As part of the devices fw upgrade process, the memory must be deleted prior to installing the new fw version.In the unit involved in this event, this step of clearing the memory was not properly followed causing the presence of bugs on the failing board.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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Event Description
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See initial.
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Search Alerts/Recalls
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