This report is based solely on the customer reported issue.The device was requested to be returned and has not been received for evaluation.A service history review, of this customer, for this device, was performed and found no similar complaints for this device.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file # (b)(4).
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Customer reported the mixer is displaying "low oxygen supply" error message.No patient incident was reported.The issue was discovered during set-up.Customer added the epgs was unable to be calibrated.It was then observed that no gas was flowing from the unit.Observed "low o2 alarm".Technician was able to manually adjust the oxygen (o2) and breathable air nitrogen (n2), oxygen (o2), carbon dioxide (co2).Observed "low o2 alarm".Concluded there is still some type of blockage in the sechrist blender with slide knob.
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