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.Operator of device and initial reporter also sent report to fda? are unknown.No information provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
|