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 07/30/2019 |
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).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) initiated an 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 message during setup.There was no patient involvement.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: through follow-up communication livanova deutschland learned that the error occurred while setting the s5 pump up for use.The device was replaced with another one.The engineer of the hospital checked the device and he duplicated 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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Manufacturer Narrative
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H.10: through follow-up communication livanova deutschland learned that this is a duplicate of a previous already reported case under mw-006679.
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Event Description
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See initial report.
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Search Alerts/Recalls
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