COVID-19 ventilator - CoVida FC100

The CoVida FC100 is a volume controlled ventilator that requires medical oxygen and medical air gas supply. The design of the device is based on an emergency and transport ventilator and is therefore only suitable for short term respiratory support. The device should only be used in a highly supervised care environment.

• Clinicians should consider the limitations of the device including those as outlined in the Instructions For Use:
  • The device failed the 3 second closed suction test: PEEP was not maintained during closed suctioning.
  • The IFU for the device states that it may take 5 minutes for the beneficial effects of PEEP to be restored after closed suctioning, and during this time the patient should be closely monitored.
  • The device has adjustability of FiO2 between 50%-100%.
  • Accuracy of delivered tidal volume may be compromised at low lung compliance.
• Full compliance with IEC 60601-1-2 has not been demonstrated for Electromagnetic Compatibility (EMC) of the device. Section 8.3.4 of the Instructions For Use (IFU) provide guidance on EMC requirements for the device. Clinical staff and clinicians must consider the implications for placement and use of these devices, i.e. during defibrillation.
• In regards to the software and control systems of the device, the manufacturer has provided limited evidence of verification and validation of the ventilator control system. The ventilator should therefore only be used in a highly supervised care environment.
• The manufacturer completed the 14 day duty cycle test on a single device.