The FDA issued a notice alerting customers of updated instructions for use with certain ventilators made by Getinge subsidiary Maquet.
This recall involves updating instructions and not removing devices, but remains the FDA’s most serious type. That means the affected device could cause serious injury or death with continued use.
Maquet issued an urgent medical device correction letter related to its Servo ventilator systems. The Servo portfolio includes the Servo-u, Servo-n and Servo-u MR devices. Updated instructions come as a result of the risk of inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients.
Before use, the ventilators must pass a safety check that measures leakage, compliance and resistance in the circuit. Some humidifiers may not pass the standard leak test due to their design, even without a leak. To address this, the settings include an optional configuration with an extended leakage test.
This test should only be used with humidifiers that can’t pass the standard leak test. If a hospital uses multiple types of humidifiers, it creates the risk of the wrong ventilator test setting for humidifier use. The outcomes could include higher displayed tidal volume than the volume actually delivered in “Pressure Control” mode. Additionally, in PRVC mode, the ventilator may deliver a lower tidal volume than the settings and display indicates.
Maquet says the issue could lead to up to a 50% difference between the displayed and actual delivered volume. This may lead to hypoventilation and hypoxia. However, external monitoring and alarms should detect these issues. Using affected products may cause serious adverse health consequences, including hypoxia and hypercapnia in extremely premature neonates.
The company reports one injury and no deaths related to the issue.
