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Covidien Puritan Bennett 840 Ventilator Obtains FDA Clearance

Covidien, a provider of healthcare products in mechanical ventilation, has received FDA 510(k) clearance to expand the Puritan Bennett 840 ventilator’s minimum delivered tidal volume down to 2ml. The feature will enable the Puritan Bennett 840 ventilator to provide ventilatory support for neonates weighing as little as 300 grams.

Covidien Puritan Bennett 840 ventilator delivers a comprehensive, user-friendly solution offering ventilation for a broad range of patients and acuity levels, from neonates to adults. Multiple therapies of ventilation help clinicians respond with the most appropriate ventilation strategy, including a neonatal continuous positive airway pressure (CPAP) mode, enabling noninvasive ventilation in neonates.

Covidien said that the ability to deliver a minimum tidal volume of 2ml will enable clinicians to safely ventilate the smallest and most critically ill neonatal patients with the Puritan Bennett 840 ventilator.

The feature will complement recent enhancements to the Puritan Bennett 840 NeoMode software, including neonatal CPAP mode and the ability to increase the fraction of inspired oxygen (FiO2) by 20% for up to two minutes during suctioning. An increased FiO2 is necessary to manage adequate oxygenation in patients who are critically ill.

Douglas Hansell, chief medical officer and vice president of respiratory and monitoring solutions at Covidien, said: “This FDA 510(k) clearance allows Covidien to make clinicians aware that one device, the Puritan Bennett 840 ventilator, can be used on all patients from newborn to adults. Now patients, from the smallest neonates in the NICU through adults in the ICU, can receive the clinical benefits provided by the Puritan Bennett 840 ventilator.”

James Willett, vice president and general manager of respiratory and monitoring solutions at Covidien, said: “At Covidien, we provide products and technologies designed to enable healthcare institutions to achieve both clinical excellence and healthcare economics goals. The Puritan Bennett 840 ventilator safely and reliably serves the needs of patients of various ages and sizes while delivering enhanced patient safety, medical efficacy and healthcare efficiency.”