This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A sample was received to perform an investigation.A visual inspection of the returned warmer found wear and tear damaged enclosure, tank cover, front cover, plate clip, and line cord.Functional testing was performed by filling the tank with water, attaching the temperature check, plugging in the line cord, and turning on the power switch.The reported problem was unable to be confirmed.The device ran all day without the pump shutting down.The enclosure, tank cover, front cover, plate clip, and line cord were replaced for cosmetic reasons and preventive maintenance was performed.A device history record (dhr) review was not performed because the results of the complaint investigation did 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.
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