Adverse Event Reporting Policy

As a medical device manufacturer, MDGenius AI is required under 21 CFR Part 803 to report to the FDA certain adverse events and product malfunctions involving the PICS platform.

• Deaths or serious injuries that our device may have caused or contributed to
• Device malfunctions that would likely cause or contribute to serious injury if the malfunction recurs
• Missed or delayed alerts that may have contributed to patient harm

• MDGenius AI Safety Team: support@mdgeniusai.com or (305) 831-1120
• FDA MedWatch: 1-800-FDA-1088 or www.fda.gov/medwatch
• Report within 30 days of awareness (5 days for death or serious injury)