Updated Use Instructions for Maquet Servo Ventilator Systems
Risk in Neonatal Tidal Volume Delivery
Maquet Servo Ventilator Systems
Source: FDA
Urgent Class I Medical Device Correction
Maquet Critical Care AB, a subsidiary of Getinge, has issued an urgent correction notice regarding its Servo Ventilator Systems (Servo-u, Servo-n, and Servo-u MR). This correction does not involve product removal, but the FDA has classified it as a Class I recall, the most serious type, due to the potential risk of injury or death if devices are used incorrectly.
Device Overview
These ventilators are used in professional healthcare settings for neonatal, pediatric, and adult patients, including in MR environments (Servo-u MR only). The devices assist or control breathing by delivering oxygen-rich air at controlled volumes.
Issue Summary
Maquet has updated its user instructions after discovering that incorrect configuration of the “Extended leakage test” could cause inaccurate compliance measurements, especially dangerous for neonatal patients. This could result in improper tidal volume delivery:
- In PRVC mode, up to 50% less tidal volume may be delivered than displayed.
- In Pressure Control mode, displayed tidal volume may appear higher than what is delivered.
Health Risks
Improper tidal volume delivery may cause hypoventilation, hypoxia, or hypercapnia, particularly in extremely premature neonates. One injury has been reported, with no deaths to date.
Recommended Actions
Issued on May 30, 2025, the correction letter advises:
- Set the “Extended leakage test” to OFF unless using a compatible humidifier (see User Manual, Chapter 8.2.4).
- Follow revised safety check instructions in Appendix 1, Chapter 9.5.1 of the user’s manual.
- Notify all affected personnel and verify all ventilators are properly configured.
Contact Info
For technical assistance, U.S. customers can reach Maquet Technical Services at 1-888-943-8872 (Option 4), weekdays 8:00 a.m. to 6:00 p.m. ET.
Read the original medical device alert here.
A Team-based Approach to an Expedited 510(k)
Getting an expedited 510(k) submission So, you have created a new medical device by following your quality system’s design controls to plan the project, define design inputs, test to verify that outputs meet inputs, and validated your production product. Now what?...
FDA Warning Letter to Olympus Medical Systems
Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA) issued a Warning Letter to Olympus Medical Systems Corp. The letter addressed several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...