Table 1.

Frequency counts, percentages, definitions, and examples of the contribution of artificial intelligence/machine learning to safety issues identified in MAUDE reports

Category	Frequency count (%)	Definition	Examples
Potentially AI/ML Related	108 (25.2%)	The MAUDE report contained language suggesting AI/ML potentially contributed to the event.	“Utilizing insulin algorithm software Monarch Endotool, a pt was administered insulin 9 units as recommended by endotool the pt was hypokalemic potassium replacement was started simultaneously with initiation of insulin the pt was transferred to the icu for dka management he became unresponsive and coded due to an unstable cardiac arrhythmia postcode the pt was found to have critically low potassium level which contributed to the code”
Unlikely AI/ML Related	173 (40.3%)	The MAUDE report did not contain language suggesting AI/ML contributed to the event.	“While inserting trocar and sleeve part of the tricuspid membrane came apart breaking off and going into abdomen device was not retrieved”
Insufficient Information	148 (34.5%)	There was not enough information provided in the MAUDE report to determine if AI/ML contributed to the event.	“Additional information will be provided once the investigation has been completed the device manufacturer date is not known at this time however, should it become available, it will be provided in future reports”