The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Avance CS2, manufactured by GE Healthcare.
The Avance CS2 may experience an intermittent display unit failure while in use, which could result in unexpected system performance and may include the loss of mechanical ventilation and balance gas delivery (Medical AIR or N2O).
According to the manufacturer, users may continue to use Avance CS2, however in the event the display goes blank, users should stop use of the device and contact local GE Healthcare Representative. If the display goes blank, an audible alarm will notify the user of the loss of mechanical ventilation. Below are the Avance CS2 safety precautions in place if this should occur:
Alt O2 automatically activates, continuing to flow O2 and agent concentration (prevailing setting) at the previous setting to the patient breathing circuit.
For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON252005
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 5 April 2013