Reference sr (b)(4).Resubmitting the mdr, the mdr was submitted to the fda on november 29, 2018 but the transfer failed.In compliance with 21cfr part 820.198- quality system regulations and natus quality management system, we initiated the investigation of the reported failure.Based on the results of the investigation, the cause of the malfunction was the use of ferrite beads that gradually degrade over the years, which burned and generated heat.Natus has determine that field corrective action is required.The fca was initiated and applicable regulatory agencies have been notified.
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