It has come to our attention that medical device manufacturer, Hamilton Medical AG, has initiated a field safety corrective action concerning HAMILTON-T1 ventilator with software version <= 1.1.2.
According to the manufacturer, there is unexpected high internal oxygen consumption of HAMIL TON-T1 ventilators during ventilation of small pediatric patients. The current labeling does not include sufficient information about the internal oxygen consumption of the ventilators. Depending on the ventilator setting and the patient's lung impedance, the internal gas consumption of the HAMILTON-T1 may be higher than expected. The internal oxygen consumption has to be taken into account in addition to the oxygen requirements for the patient's ventilation, especially when oxygen is limited. If the available oxygen supply during transport is depleted, the life of the patient may be endangered.
Furthermore, the manufacturer will rework and provide updated HAMILTON-T1 labeling (e.g., Operator's Manual), and develop and provide updated software with optimized internal oxygen consumption and overall oxygen consumption monitoring. It also advises users to calculate the required oxygen capacity prior to transports.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 04 January 2013