A 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.Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record.Per the sr, the console had a host software issue.After replacing the host module, the console was found to meet performance standards per the service test procedure (stp).The footswitch has not been returned to manufacturer for further testing; therefore, the root cause of the reported event cannot be confirmed.No service record relevant to the complaint reported event was found.Based on the information available, the customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported event is inconclusive.The root cause of the reported event is inconclusive.Therefore, no further actions will be pursued at this time.The manufacturer internal reference number is: (b)(4).
|