The reported problem could not be confirmed and this item is a distributed purchased finished good (pfg) not manufactured by smiths-medical; therefore, the dhr review is not applicable.The device was returned for evaluation.Visual and functional testing were performed.Visual inspection found no physical damage.Functional testing found the sensor probe was tested on a live patient using a good known test monitor and the probe was reading properly.The base was manipulated on both ends and no fault found during the test.The sensor probe was working properly.No problem found.The condition of the sensor probe is still in good physical condition.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.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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