According to the customer contact, on (b)(6) 2022 after the devices second use, "smoke came out of the green button." the device was in use in the home of a patient.It was reported that the device was replaced after the incident occurred.The customer contact reported that there was no injury to the patient due to the reported incident.It was reported that no medical treatment was required.The sample was evaluated but a root cause could not be determined.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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