Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device or prior repair of the device.A product sample was received for evaluation.Visual inspection and functional testing were performed.The main board was observed to be physically damaged.The monitor was tested with a simulator and all readings were accurate.A known good finger probe was used, and the readings would go in and out.During functional testing, the technician was able to duplicate the reported issue of incorrect data.Replaced the spo2 board and main board to resolve the reported issue.All readings were accurate and steady with a simulator and known good probe.The root cause of the reported issue was found to be a faulty spo2 board.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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