The customer reported that the transmitter's battery got hot and melted the case.The device was in use on a patient and the patient received a minor injury.The staff placed a cold compress on the patient.When the patient was rechecked, the minor injury appeared to resolve.The skin was flesh toned and intact.No blistering or other issues were identified, and the patient did not require additional medical intervention.The patient was discharged normally and sent home.The device was returned to nihon kohden for evaluation.Nihon kohden sent a replacement device to the customer on (b)(6) 2017.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
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