Paediatric and intensive care staff have been warned to check the settings on servo ventilators manufactured by Maquet Critical Care AB, according to the government’s medicines and health technology watchdog.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said the affected models were servo ventilators SV300 and SV300A with an automode function.
According to the medical device alert, there is a risk of inadequate ventilation of neonatal or paediatric patients without warning by any alarm.
Automode is a function where two consecutive breathing efforts from the patient will shift the ventilator from control to support mode. It remains in support mode as long as the patient keeps breathing – but if the patient stops it shifts back to control mode.
The MHRA said it was aware of an incident where a reduced inspiration time occurred, with no alarm, during ventilation of a neonate with a servo ventilator 300A.
The automode was on with the trigger level set to the minimum and the patient had no spontaneous breathing, resulting in inadequate ventilation.
Staff are urged to ensure the set inspiratory rise time is in the range 7-10% and the water level of the humidifier chamber is maintained according to the manufacturer’s recommendations.
For more details, see the attached Medical Device Alert.