The FDA has alerted users to updated instructions for certain neonatal ventilators from Getinge subsidiary Maquet, classified as a serious device correction rather than a recall.
The update affects the Servo ventilator systems, including Servo-u, Servo-n, and Servo-u MR models. It addresses risks related to inaccurate compliance measurements that may cause improper tidal volume delivery in neonatal patients.
Specifically, some humidifiers fail standard leak tests due to their design, prompting the use of an extended leakage test configuration. Incorrect test settings—particularly in hospitals using multiple humidifier types—could cause displayed tidal volumes to differ by up to 50% from actual delivery. This discrepancy poses risks of hypoventilation and hypoxia, especially in premature neonates.
Maquet reports one injury linked to the issue but no fatalities. External monitoring and alarms are expected to detect ventilation problems.
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