The Australia Therapeutic Goods Administration (TGA) has issued a medical device safety alert concerning SERVO-i/s ventilator systems with software version 8.00.00 [Part numbers: 68 85 247, 68 85 259].

The manufacturer has become aware of improper behaviour introduced in SERVO-i and SERVO-s ventilator system SW version 8.00.00, which appears as follows:-

• If ventilation is started with Infant factory default settings, the following settings will apply: Pressure Control mode; and 10 cmH2O PC above PEEP.
• The system will deliver a pressure of 20 cmH2O above PEEP as long as the factory default setting 10 cmH2O is used unchanged.

According to the manufacturer, there is a risk of serious injury to an infant. However, the issue would be apparent in the pressure curve and peak pressure displayed on the screen. There are no reported injuries.

Users are advised to change the default settings of pressure above PEEP in the infant patient category. The ventilator will only deliver a pressure of 20 cmH2O above PEEP if the default start-up configuration of the pressure has not been changed. The manufacturer will be upgrading all affected units as a permanent correction.

According to the local supplier, the affected products are NOT distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 June 2016