This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Udi information is unknown.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.Wear and tear damaged enclosure, tank cover, front cover, line cord, plate clip, and pole clamp.Out dated power control board and power switch.Noisy pump.Started with a visual inspection then filled tank with water, attached temp check, plugged in line cord, and turned on power switch.The root cause of the reported issue was found to be a shorted out power control board.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.A corrective and preventative action has been opened to address the reported issue.
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