H10 h3, h6: the device, intended for use during treatment, was returned for investigation.The initial functional inspection of the returned siu found that the device received a 40000000000-error message when powered on.This was indicative of fuse damage.The dhr was reviewed for the device at the time of manufacturing and passed all tests.Therefore, the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar similar reports of the issue.The relationship of the device and the reported event has been established.The error message is caused by a blown fuse in the siu.The root cause of the reported event was due to electrical component failure.
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