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.The device was returned for evaluation.Visual and functional testing were performed.Visual inspection found the carbon dioxide pump top was found open and the pump was shift out of position.Functional testing was able to duplicate the reported problem.The root cause of the reported issue was found to be a contamination clog internal components, impact to the monitor.The carbon dioxide pump, carbon dioxide bench, internal tubing kit, naphion tube and absorber will need to be replaced.Operator of device is unknown.No product information has been 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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