Regulatory news: Maquet gets FDA OK for upgraded SERVO-i Ventilator System

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Maquet Critical Care received FDA 510(k) clearance for an upgrade of its SERVO-i Ventilator System for conditional use in the magnetic resonance (MR) environment. The SERVO-i ventilator is intended for treatment and monitoring of all patients—neonatal, pediatric and adults—who require mechanical ventilation. The new SERVO-i MR environment option is capable of providing critically ill patients with advanced ventilatory care using the same machine wherever they are in the hospital—in the ICU, in the MR examination room and during transport to and from the MR room.

To produce scans, MR equipment must generate strong magnetic fields that have a potentially dangerous downside: injury or death can occur when ferromagnetic objects are pulled into the center of the magnet. This risk severely limits the types of medical devices that can be used during MR examinations.

Previous ventilators specifically designed for safe use in the MR examination room tend to have significant limitations. The SERVO-i MR environment option allows patients who require an MRI exam to stay connected to the same SERVO-i ventilator that serves them in the ICU.

SERVO-i’s MR environment option has been tested with several MR scanners including 1.0, 1.5 and 3.0 Tesla MR units.