Additional information provided in h.3., h.6., and h.10.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.Service history was reviewed for the system.There was no service record (relevant to the reported event), 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.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint was determined to not be relevant to this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
|