H3: it is currently unknown if product is available to be returned for evaluation.Therefore, this report is based solely on the information provided by the customer.Complaint was reported to the manufacturer by the end user directly via an online feedback portal.We have attempted to contact the customer at the email address provided but have so far received no response.There is no lot information available for the affected product, so the device history record could not be pulled for review.At this time, there is no evidence that a manufacturing error contributed to the reported failure.Based on historical complaint data and information currently available, likely root cause is due to new users and device training issues.There have been a total of 3 complaints for this failure mode and product family in the last 2 years.Based on sales data, this issue has a complaint rate of (b)(4) during that time.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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