During inspection and testing, error e03 and an intermittent power issue was observed.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, error e03 indicated a malfunctioning main board, and the intermittent power issue indicated a malfunctioning power cord.However, a definitive root cause of the reported issue could not be identified.According to the service manual, e03 indicates pipeline pressure sensor error, and its probable causes are connection failure of the connecting tube connected to the pipeline pressure sensor or faulty main board.Olympus will continue to monitor field performance for this device.
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A user facility returned the olympus asset, high flow insufflation unit, to the olympus service center.Upon inspection and testing of the returned device, error e03 was observed indicating a malfunctioning main board and an intermittent power issue was identified.This report is being submitted for the event found during evaluation.There was no patient involvement.
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