Covidien, Boulder, Colo, received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Leak Compensation software feature for the Puritan Bennett 840™ ventilator system. According to Covidien, the option provides continuous levels of mechanical ventilation to patients requiring respiratory support, regardless of the level of gas leakage that might occur in the circuit or past a patient interface device in the clinical setting.
The Leak Compensation software for the Puritan Bennett 840 ventilator automatically adjusts for leaks of as much as:
10 liters per minute (lpm) for neonates with an ideal body weight as low as 0.5 kg;
40 lpm for pediatric patients; and
65 lpm for adults.
“Gas leakage presents a challenge in high-leak environments, particularly during noninvasive ventilation where leaks associated with the use of masks, nasal prongs, and nasal pillows frequently occur. These leaks can contribute to significant asynchrony between a patient and the ventilator, which in turn might impede weaning and increase the time that the patient is ventilator-dependent,” said Roger S. Mecca, MD, vice president, Medical Affairs, Respiratory and Monitoring Solutions, Covidien, in an announcement. “Covidien now offers software that quickly adjusts for leakage, improving patient-ventilator synchrony and triggering. It is especially valuable for preventing auto-triggering when the leakage rate exceeds the flow-triggering threshold.”
The Puritan Bennett 840 ventilator system with Leak Compensation software is intended for use in hospitals and similar medical care facilities. It may also be used during transport within such facilities if appropriate electrical power and compressed gas sources are available.