Healthcare Industry News:  Magnetic Resonance Imaging 

Devices FDA

 News Release - March 2, 2007

MAQUET Critical Care Receives FDA 510(K) Clearance for New Option Allowing Use of its Servo-I Ventilator During MR Exams

Bridgewater, NJ, March 2, 2007 --(HSMN NewsFeed)-- MAQUET Critical Care announces that they have 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. Typically pneumatically powered ventilators lack some of the key features of ICU ventilators, including high flow and high airway pressure capabilities, advanced ventilation modes, and monitoring and alarm systems. In addition, hospital personnel may not be familiar with their operation. But now--thanks to the SERVO-i MR environment option-- patients who require an MRI exam can stay connected to the same state-of-the-art SERVO-i ventilator that serves them in the ICU.

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

The SERVO-i MR environment option has been classified as “MR conditional,” meaning it is safe for operation in the MR examination room provided that certain conditions are met. These conditions are described in-depth in the SERVO-i MR Environment Declaration, which is included in the SERVO-i MR environment kit.

For more information regarding the SERVO-i MR environment option, please email or call 1-888-MAQUET3 (ext: 2306)

Source: MAQUET Critical Care

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