The mlx 300 xenon lightsource w/australian power cord (00mlxau) has been returned for evaluation: dhr review: a review of the dhr was not performed, as the described complaint is being addressed per quality plan and is not related to a manufacturing non-conformance.Failure analysis: this described failure is being addressed by internal quality plan for issues relating to power supply, hard start issues, and early-life failure of the lamp module.As an interim solution, integra can replace components of the mlx lighting units to restore functionality.Root cause: the issue of power supply failure is being investigated under internal quality plan to address root cause and corrective actions.
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A facility reported that the xenon lightsource w/australian power cord (00mlxau) was not switching on and had blown fuses.The fuses blew again after replacement.It is unknown if there was patient involvement; however, no patient injury, death or surgical delay was reported.
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