Engineering evaluation is not able to be performed as the sensor is with a new patient.The sensor as of 23nov2022 has been functioning as intended and without further allegation.Due to the continued function of the sensor, it did not likely experience an overheat event.The images provided exhibit skin irritations at the site of electrode placement.It is most probable cause of the skin issue is that the patient experienced a bio-incompatibility event to the electrode that was perceived as a thermal event.Electrodes are single use devices.In this case the electrode was not returned for evaluation.Allegations of third degree burns, smoke, and fire could not be confirmed.The electrodes were not available for return by patient as these are single use devices.The electrode was the biotel universal patch that was worn by the patient at the time of the event.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.
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