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.A product sample was received for evaluation.Visual and functional testing were performed.The technician found out that the red light emitting diode (led) was damaged due to impact.The technician performed the functional test and reported issue of top red led does not flash when alarming was duplicated.The mainboard was also damaged.The technician replaced red led and mainboard to resolve the reported issue.The device operated as intended.The device passed all the functional and electrical testing.The root cause of the reported was determined to be related to the customer's impact to the device.Operator of device is unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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