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Maquet Critical Care AB, a subsidiary of Getinge, is updating use instructions for Servo Ventilator Systems due to risk of inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients.
The Servo ventilator systems can be used with several different patient circuits and active humidifiers. Before being used on a patient, the ventilator 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 if there’s no actual leak. To address this, there is an optional configuration for the ventilator with an “Extended leakage test” in the ventilator’s Service & Settings menu.
This extended test should only be used with humidifiers that cannot pass the standard leak test. If a hospital uses multiple types of humidifiers, there’s a risk that the ventilator could be set to the wrong test for the humidifier in use.
This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with questions about this recall should contact technical services at 1-888-943-8872, Option 4, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. ET
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