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Covidien receives FDA clearance for new ventilator leak compensation software

Published on August 6, 2009 at 7:28 PM · No Comments

Covidien has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Leak Compensation software feature for the Puritan Bennett 840 ventilator system. This 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.

During either invasive or noninvasive ventilation, air leaks past a mask, nasal prongs, nasal pillow, supraglottic airway, endotracheal tube or tracheostomy tube can result in loss of gas volume, potentially causing subsequent dysynchrony between a patient's spontaneous breathing efforts and the ventilator's response.

The Leak Compensation software for the Puritan Bennett 840 ventilator automatically adjusts for leaks of up to:

  • 10 liters per minute (lpm) for neonates with an ideal body weight as low as 0.5 kg
  • 40 lpm for pediatric patients
  • 65 lpm for adults

The Leak Compensation software also minimizes potential guesswork in determining the appropriate settings required to compensate for leakage.

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