Model Number 25-40-45 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The device has been requested back to the manufacturer site for a detailed 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 gas blender system displayed an error code and the device stopped working during setup.There was no patient involvement.
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Manufacturer Narrative
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H.10: deviation could be reproduced during the investigation.The root cause was identified on the defective microcontroller.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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Event Description
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See initial report.
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Search Alerts/Recalls
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