Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens).
The Servo ventilators 300 (SV300) and 300A (SV300A) are intended for general and critical care ventilation of adult, paediatric and neonatal patients.
Affected ventilators are those with an automode function. Automode is a function where two consecutive breathing efforts from the patient will shift the ventilator status from control mode to a support mode. The ventilator will remain in the support mode as long as the patient keeps breathing; if the patient stops breathing the ventilator will shift back to the control mode.
The Servo-I ventilator is not affected by this issue.