Evaluation of the xenon lightsource (00mlx) was not performed as the device was not returned to the manufacturer.The device history record (dhr) was not reviewed as the reported complaint of the unit blowing fuses and not powering on is being addressed by internal quality plan and is not related to a manufacturing non-conformance.As an interim solution, integra can replace components of the mlx lighting units to restore functionality should the customer later return the device.At present, we consider this complaint to be closed.Trends will be monitored for this and similar issues.
|