Artificial intelligence related safety issues associated with FDA medical device reports.

Patient safety reports submitted to the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database provide a rich source for identifying how artificial intelligence/machine learning (AI/ML) may have contributed to the event. This study identified 429 safety reports associated with AI/ML-enabled medical devices; one-quarter were potentially related to AI/ML, underscoring the need for an AI patient safety program.