Date received by mfr: (b)(6) 2019.The manufacturer¿s international service technician confirmed the reported battery issue.The manufacturer¿s international service technician replaced the battery to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.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.
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