There was no patient involvement.Event date has not been provided.This information will be provided in a supplemental report if made available.(b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The device was returned to livanova (b)(4) for repair.The technician was not able to confirm the reported issue.The device was calibrated and subsequent functional verification testing was completed without issues.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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