Corrected information has been provided in h.7.Remedial action is na and not modification/adjustment as previously reported.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.There is no evidence that the design or performance of the equipment caused or contributed to this reported event.¿ the manufacturer internal reference number is: (b)(4).
|