First time in for service after 2 years in the field and the reported problem is a user perception resulting from user interfacing with the unit in a manner inconsistent with the ifu.It is a normal operation of the spectro2 to alert the customer when no reading is being acquired or no patient is being detected because a patient is not attached.The dhr review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.No information provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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