COVID-19 ventilator - Ventasys-E

The Ventasys-E is a pressure controlled ventilator, which additionally incorporates PC-SIMV mode (validation data for which has not been provided to the TGA).

EMC testing in compliance with IEC 60601-1-2 (or other applicable standard) has not been performed; users must consider implications on placement of these devices. Documentation regarding software architecture and design specification has not been provided to the TGA, although risk analysis, testing and validation has been demonstrated.

Closed suction testing was failed, though it was noted pressure drops were of short duration and did not result in negative pressure.

Two ventilators were tested for the 14-day duty cycle and performed as intended.