A product sample was received at the investigation site.Visual and functional testing were performed.Visual inspection found no visible sign of physical damage on the housing or main board components.Functional testing found reported problem was able to be duplicated.The root cause was determined to be faulty main board.Device history record (dhr) review is not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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