Model Number 10-80-00 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 testing was completed without further issues and the unit was returned to service.The touch screen 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 display became unresponsive during procedure.There was no report of patient injury.
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Manufacturer Narrative
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The touch screen was returned to livanova (b)(4) for further investigation.During the evaluation it was found that the ito layer was scratched and fluid ingress was found on the touch screen.Therefore livanova (b)(4) determined that the fluid ingress was the root cause of the reported malfunction.This is a known issue and livanova (b)(4) implemented a new sealing as corrective action to prevent the reported malfunction.
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Search Alerts/Recalls
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