Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found damaged front bezel and monitor tamper seal was removed.Functional testing found the display was blank, the display was replaced and worked as intended.For the occlusion problem, the main board and bench had to be replaced to resolve the error.The root cause of the reported issue was found to be user impact damaging the display and failing to follow operational manual.Operator of device is unknown.Initial reporter also sent report to fda is unknown.This remediation mdr was generated under protocol(b)(4), as a result of warning letter cms# (b)(4).
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