Model Number 25-40-40 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.The gas blender system 25-40-00 is not distributed in the usa, but it is similar to gas blender system 25-40-45, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in bad (b)(6).The affected part has been requested back to the manufacturer site for a detailed investigation.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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Livanova (b)(4) received a report that a s3 gas blender system displayed an error message during priming.There was no patient involvement.
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Manufacturer Narrative
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The reported error could not be duplicated during the investigation.
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Manufacturer Narrative
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H.10: through follow up communication livanova learned that the issue was confirmed afterwards and the customer rejected the repair.
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Event Description
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See initial report.
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Search Alerts/Recalls
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