This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed large cracks on water tank cover around the bolts and front cover, loose screw inside.Old style printed circuit board and drain fitting.Customer?s reported issue was duplicated.Bent ground prong on-line cord caused the issue.The root cause of the issue was determined to have been caused by the customer.Actions taken to mitigate the reported issue: no action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.Udi information is unknown.
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