Evaluation of the Puritan Bennett™ 980 Ventilator System Safety and Performance in the Real-World Setting.

Purpose: Mechanical ventilation is a life-supporting intervention but is associated with known risks and complications. To improve the efficacy and safety profile of mechanical ventilation, manufacturers have developed advanced ventilator settings, modes, and alarm strategies to optimize ventilation for patient needs while avoiding complications. However, there is little real-world data published on the deployment of ventilator technology. The main objective of this study was to assess the clinical safety and performance of the Puritan Bennett™ 980 Ventilator System (PB980) using real-world clinical data collected from a diverse, global patient population. Methods: This was a multi-center, post-market registry study that included nine sites: four in the United States of America, one in Europe, and four in China. Patients were enrolled into the registry if they were intended to be treated with a PB980. Data collection began at the start of ventilation and continued until extubation off the ventilator or up to seven days of ventilation, whichever occurred first. Subjects were divided by age into three categories: infants (0-365 days), pediatric (1-17 years), and adult (18 years and older). The primary outcome was device-related complication rate. Results: Two-hundred-and-eleven subjects were enrolled (41 infants, 48 pediatric, and 122 adults). Sixteen deaths, unrelated to device deficiency, occurred during the data collection timeframe (relative frequency: 7.58, 95% CI: 4.40, 12.0). Only one device-related adverse event was reported (relative frequency: 0.47% 95% CI: 0.01%, 2.61%). Conclusion: Ventilation by the PB980 was delivered safely in this multi-center observational study, which included a diverse sample of patients with broad ventilatory needs.