The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed that there was loss of image and uncontrollable buttons activation when the cable is flexed near the stain relief.The complaint was confirmed and the root has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the failure includes; an internal damage to the cord.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.A complaint history review concluded this was a repeat issue.Internal complaint reference: (b)(4).
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