It was reported that the device allegedly caused a crackling noise, smoke from an electrode and resulted in a 3rd degree burn to the patient that was being treated.It was initially reported to enovis that the patient experienced only a brown demarcation with surrounding redness and that the patient stated, "oh, that's nothing, i'm fine".Enovis performed an inspection on the actual device returned.The unit passed functional and safety testing.The product met manufacturer specifications.Possible root causes include moisture or misapplication of the electrodes.(response to mw5111204).
|