The customer confirmed they will not be returning the device.This event is reported solely on the information provided by the customer.Historical review of the complaint database found 4 other event with similar issue where the patients were able to maneuver around the mitts.Of the 4 complaints, product was returned for only one of the complaint.Analysis of the device found it to have met specifications and functioned as designed.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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