Evaluation of the returned device did not confirm the reported issue.The unit was tested per internal testing procedures, and the unit performed per the test criteria and no observations were made.A dhr review found 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.(b)(4).
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