The company service representative examined the system and was unable to confirm or replicate the shut-down issue.As a preventative measure for the shut-down issue, the power supply, and the power distribution printed circuit board (pcb) were replaced.The company service representative confirmed the odor issue.However, the company service representative was unable to diagnose the root cause of the odor while on-site.The system was then tested and met all product specifications.A system non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The root causes for the shut-down and odor issues are inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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