We hooked a patient up a few weeks ago.The patient told them to keep turning it up, they couldn't feel it, which resulted in 3rd degree burns.The low pads were 1st degree the lower pads are 3rd degree and he also no longer has no nerve ending.He is not ok but he is not hospitalized.Unit has been used since around 2018.The patient did not have access to the safety stop switch and the clinic is not sure that this is something that they currently have.Information from the word trigger form: device was being used in a chiropractors office by a chiropractor aid.The end user is a male, 28 years old, about 220 lbs and 5'11".Device is 7 years old and has been in use since 2018 according to the clinic.There were no other devices being used at the time of the event.The burns showed up immediately after treatment.They were using 4 electrodes in a criss-cross pattern.A modulating program was being used, the acute therapy program.The lead wires were replaced either this year or last year they are not exactly sure.(4) 2x2 self adhesive electrodes were used, they are not sure if they are new or had previous use, they were placed about 5 inches apart, and being used on the lower back.No conductive spray or solvent was used.Electrodes are not being shared between patients.An alcohol pad was used and dried completely before placing electrodes.Electrodes were placed on clear skin.The burn is still presents after 2 weeks.The burn happened on (b)(6) 2022.The burn is still present but the patient did not show back up for their appointment.The chiropractor does not have the medical records from the emergency room but may be able to obtain them.Electrodes are stored in their bag in a cabinet in-between uses.Compass health electrdoes, part # ef2020wf2 are being used.There are no exposed wires or damage noted on the lead wires.Patient has no known allergies.Ifc-4p was being used with a pulse rate of 80/150 and the frequency modulation was 10,000hz.Customer does not know what channels this was happening on.The likely root cause of this event was determined to be user error because the customer did not provide the patient with the kill switch and the device was set to the highests frequency modulation setting.They do not know if the lead wires have been replaced; these require replacement at least yearly.
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