Model Number 10-80-00 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/20/2018 |
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 defective touch screen.The technician replaced the touch screen to resolve the reported issue.Subsequent functional verification was completed without further issues and the unit was returned to service.The touch screen was requested back 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 a s5 roller pump touch screen became unresponsive during priming.There was no patient involvement.
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Manufacturer Narrative
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The defective touch screen was returned to livanova (b)(4) for further investigation.During the evaluation the reported issue could be confirmed.As root cause fluid ingress in the device could be determined.Livanova (b)(4) implemented a new gasket as corrective action for the reported issue.
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Search Alerts/Recalls
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