Evaluation of the Ventilator System Safety and Performance in the Real-World Setting

Introduction: Mechanical ventilation is a life-supporting intervention for patients with respiratory failure or critical illness 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 make ventilation more optimal for patient needs while avoiding complications. However, there needs to be more 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: Multi-center, post-market registry study that included 9 sites, 4 in the United States, 1 in Europe, and 4 in China. Patients were enrolled into the registry if they were intended to be treated with a PB980 ventilator. Data collection began at the start of ventilation and continued until extubation off the ventilator or up to 7 days of ventilation, whichever occurred first. Subjects were divided by age into 3 categories: infants (0-365 days), pediatric (1 – 17 years), and adults (18 years and older). Outcome variables included: device-related complication rate, device deficiencies, device-related adverse events, duration of ventilation, and device performance.

Results: 211 subjects were enrolled across three age groups (41 infants, 48 pediatric, and 122 adults). 16 deaths, unrelated to device deficiency, occurred during the data collection timeframe. Only 1 device-related adverse event was reported, an expiratory filter blockage during the ventilation, and the patient was immediately transferred to another ventilator to avoid obstruction.

Conclusion: This is the first study to report PB980 ventilator-related safety and performance as a primary outcome in a real-world setting on a large sample of diverse patients. Using real-world, global data, this study supports the safety and performance of the PB980 across a diverse group of patients with a wide variety of ventilation settings and modes.