Additional information: imdrf annex a, g, b, c and d grids and manufacturer narrative (chr, dhr and shr).Device evaluated by bd servicez: a review of the complaint history for sn: (b)(6) was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 15sep2017.The review was performed from the date of manufacture to the present date 09jun2021.A review of the device history record for sn: (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the service history record for sn: (b)(6) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.
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