If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the unit was evaluated and the reason for return "the suction is not working" could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.This device was produced prior to the closure of the fms facility in nice, france and therefore will not have a device history record (dhr) review preformed.This report is being filed from the (b)(4) as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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