The returned device first time in for service after 1 year in the field and the reported problem is a user perception resulting from user interfacing with the unit in a manner inconsistent with the instructions for use (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 device history record (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.Lot # and initial reporter also sent report to fda are unknown.No information provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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