This event was initially considered to be non-reportable.However, after additional evaluation, livanova deutschland has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Patient information was not provided.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).The defective switch was requested back to livanova (b)(4) for further investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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