A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; the unit is damaged.During triage, factory service found the unit had a damaged power cord with exposed copper wires.Therefore, this report will be based on information provided by the technical center.The scd express was evaluated and the customer reported issue of damaged along with factory service finding of damaged power cord with exposed copper wire were both confirmed; problem was isolated to damaged power cord.Visual examination revealed damaged power cord with exposed copper wire.The cause of the reported condition for the damaged power cord is due to customer related accidental damage.The damaged power cord will be scrapped to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.Scd express was manufactured in 2006.A review of the device history record shows this device was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Based on the investigation, no corrective action is needed.
|