Pma/510k : 13dec2019, date of report : 20dec2019.The field service engineer replaced the blower assembly which corrected the noise issue and discovered during the repair the device an additional issue the machine will automatically switch on and off, and sometimes can not be started or shut down.The field service engineer (fse) replaced the power switch overlay to address the reported issue.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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