The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with short circuit detected error and a burnt resistor on main pcb.Cause of failure is a defective electronic component.The complaint was confirmed and the root cause has been determined to be defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
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