FDA 483 - Amplion Clinical Communications, Inc. - February 16, 2023

An FDA inspection of Amplion Clinical Communications, Inc. in Nashville, TN, a specification developer, revealed a significant failure in their medical device reporting (MDR) process. The firm did not submit MDR reports within 30 days for two complaints involving their Patient Station (PAS) device, where Code Blue and STAT alarms allegedly malfunctioned during events where patients stopped breathing. These malfunctions were identified as having a potential impact on patient safety, with the risk management file indicating they could lead to delayed assistance, injury, or death, yet the firm's investigations failed to classify them as device malfunctions.