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.Service history was reviewed for the system.There was no service record (relevant to the complaint), found.However, the system was last serviced prior to the reported event per service record (sr).The system found to meet all cosmetic and performance standards.An internal investigation was opened to address this issue, it was later determined to be irrelevant to this investigation.A review for complaints reported against this serial number was performed.Five potentially relevant complaints were found and reviewed as part of this investigation.The customer reported event cannot be confirmed.Thus, based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
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