Additional information: the customer suspected the cause of the reported event was attributed to a non-conforming electrical outlet in the operating room.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.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on october 23, 2006.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.(b)(4).
|