The reported issue could not be replicated.However, the investigation found the power amplifier was damaged.Due to the damaged power amplifier, the waa may feel warm while charging.The waa is unable to provide therapy while charging; the patient would not be using the unit at this time.For the report of overheating: thermal imaging was used to verify the outside temperature of the device while operating, outside temperature while charging, and the internal temperature while operating.Results are as follows: outside thermal temperature while operating: 30.7°c.Outside thermal temperature while charging: 32°c.Internal thermal temperature while operating: 57.2°c.The outside thermal temperature while charging was 32°c, which is below the product requirements specification of 41°c (106°f).Based on the thermal imaging, there is no evidence of thermal damage and the product met temperature specifications.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in blown power amplifier.Blown power amplifier rates remain acceptably low; thus, capa is not required.Blown power amplifier rates will continue to be tracked and trended.
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