CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Draeger has issued a letter to affected customers recommending certain VentStar Resus Neo hoses be removed from where they are used or sold.
Affected devices:
Product Name | Model | UDI |
|---|---|---|
VentStar Resus Neo | MP00310 |
What to Do
These devices are used in critical and emergency situations. Users should review and follow the recommendations below to inspect and remove affected product prior to use.
On September 1, Draeger sent all affected customers a letter recommending the following actions:
- Carefully inspect the hoses for damages prior to use according to the product’s Instructions for Use (IFU).
- Discard products that show cracks (Figure 1) or have a detached hose (Figure 2). You do not need to return them to Draeger.
Figure 1. Cracked hose.
Figure 2. Detached hose.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Draeger stated that they are aware of cases in which obvious cracks in the hose of the VentStar Resus Neo were detected by the users prior to use.
If a cracked hose is used, the hose may fall off or leak resulting in restricted ventilation or delayed therapy which could lead to desaturation, hypoxia, or patient death.
As of August 27, Draeger has reported no serious injuries or deaths associated with this issue.
Device Use
The VentStar Resus Neo is a disposable breathing circuit used to convey breathing gas from a source to an infant (up to 22 lbs).
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Draeger at 445-224-0698 or karina.howard@draeger.com.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.