678: 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 nine sites: four in the United States, 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 7 days of ventilation, whichever occurred first. Subjects were divided by age into three 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). Sixteen deaths, unrelated to device deficiency, occurred during the data collection timeframe. Only one device-related adverse event was reported, related to an expiratory filter blockage during ventilation. The ventilator alarm appropriately indicated an expiratory filter warning, and the patient was immediately transferred to another ventilator to avoid obstruction. The complication did not appear to result in any short or long-term detriment to the subject’s health. Conclusions: Using real-world, global data, this study supports the safety and performance profile of the PB980 across a diverse group of patients with a wide variety of ventilation settings and modes.