This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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.Visual inspection observed that the device was in poor condition with external labels and components.During functional testing, the reported problem was duplicated.The root cause of the reported issue was found to be the normal wear and tear on the power switch.Due to the age and upgrades needed, the device was deemed beyond economical repair and will be scrapped.A corrective and preventative action has been opened to address the reported issue.Udi) is unknown.No product information has been provided to date.
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