The customer reported the unit was repaired in their corporate branch.The unit was returned and it¿s working properly.The determination could not be made that the device failed to meet specifications.There is a relationship of the device to the reported problem.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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