The mx40 patient worn monitor device (¿device¿) was returned to philips on march 23, 2021.The lead set, aa batteries, and battery adapter tray involved in this incident were not returned to philips for evaluation, nor were pictures provided.The fse requested additional information on the incident reported above and was informed by your hospital that the nurse reported the lead set was warm, but no heat was felt on the mx40.The fse was also informed the lead set was discarded and the lot number is unknown.The burn was treated with cream and band aids.It was reported that the battery adapter tray involved in the reported incident was corroded and discarded.A philips product support engineer (pse) examined the device.The pse found that there was no corrosion or chemical residue at the connector pins or battery contacts.The gore-tex vent cover inside the battery compartment is discolored (yellowed).This is typically chemical related and is consistent with use of bleach.The pse then performed testing on the device and the device was powered on using 3 aa batteries and connected to a product support engineering lab patient simulator (with pse lab patient cable).The device was operated for one hour, with no overheating of the batteries or device.During operation, the device alarmed as appropriate for simulated heart rate conditions.The device spontaneously rebooted three times while it was in operation.One reboot occurred when the device was picked up and tapped lightly on the side.This may be due to the wear to the battery adapter tray that was returned with the device.Measurements were performed at the device connector using a multi-meter while the device was powered on.No shorts were measured, and no voltage was measured that would cause burns or shocks to a patient or user.The aa batteries and battery adapter tray were removed from the device and a pse lab philips rechargeable li-ion battery was inserted into the device.The device was operated for one hour, with no overheating of the device or battery.During operation of the device with both aa batteries and a philips rechargeable li-ion battery the patient cable/leads did not get hot.The device¿s speaker produced clear, audible tones during operation (including for generated alarms).The patient cable that was in use at the time of the incident was also requested for evaluation; however, it was not returned with the device.The condition of the cable is not known.Note that the patient cable cannot generate energy that would shock or burn a patient or user.Based on our investigation, there is no evidence that the mx40 patient worn monitor device overheated or delivered energy through the connector that would have caused a burn to a patient or user.The device was returned to the customer.
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