Other, other text: this remediation 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.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found wear and tear damage to drain fitting, enclosure, water tank cover, front cover, line cord, pole clamp, and 390 block.Functional testing was performed by filling the reservoir with water, attached temp check to hotline, plugged in line cord, and turned on power switch to perform safety/electrical testing.The reported problem was duplicated.The root cause was found to be a faulty printed circuit board.The printed circuit board was replaced.
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