Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower
MedSun: Newsletter #81, February 2013

FDA MedWatch Safety Alert

During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 ventilators with software versions 1.1.2 and lower. This may cause miscalculation of the required oxygen needed for long time applications with limited oxygen supply.

Additional Information:

FDA MedWatch Safety Alert. Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower. February 7, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm338789.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun