The complaint was dispatched to the field service engineer (fse) department for further investigation.The fse found the degasser vacuum pump failing.Fse replaced the degasser vacuum pump and ran quality controls, results were within range and without any errors.The instrument is functioning as intended and was released.No further actions are required by the fse.The g8 instrument, serial number (b)(4) was installed on the (b)(6) 2018.A complaint history review and service history review for similar complaints was performed from (b)(6) 2018 through aware date the (b)(6) 2018.There were no similar complaints found during the searched period.A review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The g8 variant analysis mode operator's safety precautions states the following: for repair, contact technical support fires, electrical shocks and other problems may occur if the instrument is disassembled, repaired or remodeled by yourself.
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Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, (b)(4), per exemption number e2017013.Device evaluation by manufacturer.The vacuum pump was returned for further evaluation.Functional testing was performed on the vacuum pump and the reported error was duplicated.The vacuum pump failed functional testing and will be discarded.The most probable cause of the reported issue is due to the vacuum pump.
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