Additional information: device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer?, if other specify, imdrf annex a, b, c, d and g grids and manufacturer narrative (chr and dhr statements) omit: (b)(6)- no audible prompt / feedback (2282), g0600101 - alarm, audible, b17 - device not returned, c20 - no findings available, d15 - cause not established a review of the complaint history for this serialized unit did not confirm similar complaints, based on the same or related failure mode for this event.A review of the device history record was performed from the date of manufacture to the date of product release for distribution which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Not applicable.Device evaluated by bd.
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