G4: 03jan2020.B4: (b)(6).The customer's bio medical engineer (biomed) confirmed the failed battery test.The customer's biomed replaced the battery and the device is back in service.The determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.Part was not returned to failure investigation (fi).The root cause cannot be determined until the device is returned and investigated.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.
|