The alleged event was not confirmed by the manufacturing plant.The device was not returned to the plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
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Biomedical technician from a hemodialysis clinic reported observing smoke coming from the machine when in heat disinfect mode.Technician replaced the actuator board, functional sensor and when re-connecting the machine, observed the smoke.No damage was observed on any of the components.Additional information was solicited.
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