During inspection and testing, service found the excessive pressure warning light was not working as designed and the main board was found to be faulty.A review of the device history record found no deviations that could have caused or contributed to the warning light not working.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the warning light did not work as designed due to the faulty main board.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.The reported issue (long time to pressure up) was not reproduced during testing.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
|