The system was examined.And the reported event was replicated.The company representative, resolved the issue by replacing the pneumatics module.The system was tested and found to meet specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to nonconforming pneumatics module.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|