H10: h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A visual inspection observed a scratched bezel.A functional evaluation revealed the unit does not power on when the button is pressed.The leds on the power supply do illuminate when plugged in.The unit was opened and found the cabling to the power button was loose from its housing.The complaint was verified and the root cause was determined to be a component failure.Factors that could have contributed to the reported event include failure of the power button or power button components.No containment or corrective actions are recommended at this time.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.
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