Investigation of Probable Causes of Patient Damage in the Multifactorial Environment of Adverse Events: Analysis of Adverse Event Notifications for Pulmonary Ventilator

Pulmonary ventilator is a medical equipment of big impact in patients with lung conditions or during anesthesia, making it important to evaluate the adverse events related to it and to place them in their context of occurrence. To this end, an analysis of adverse events was performed from 2011 to July 2021 based on the Food and Drug Administration (FDA) and National Health Surveillance Agency (ANVISA) platforms, along with a review of the literature on causes and contexts in which adverse events occur. In the FDA database, more than 100,000 notifications were found, with equipment defects related to display, operability, and mechanical problems predominating. The events of damage to the patient were mainly death, cardiorespiratory arrest and oxygen desaturation. On the ANVISA platform, 131 notifications were found, including complications related to the airflow of the device. Damage to the patient was, mainly, death, cardiorespiratory arrest, and respiratory failure. Applying the classification of adverse events of the Emergency Care Research Institute (ECRI) the reports of the American base, it was verified that the events were entirely caused by ventilator defects. Events related to problems intrinsic to pulmonary ventilators preponderated, a fact that is not consistent with the researched literature, which demonstrate the importance of the systemic approach to the complex environment in which adverse events occur. This study reinforces the need to generate evidence of problems related to the use of technologies for the investigation of causes, and to apply Clinical Engineering in management of health technologies in a safer way.