Draeger issued a letter to affected customers recommending certain VentStar Resus Neo hoses be removed from where they are used or sold, according to an FDA early alert.
According to the FDA, Draeger is 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, the FDA reports.
The VentStar Resus Neo is a disposable breathing circuit used used in critical care and emergency care to convey breathing gas from a source to an infant (up to 22 lbs).
As of August 27, Draeger has reported no serious injuries or deaths associated with this issue, according to the FDA.
Affected Devices
| Product Name | Model | UDI |
|---|---|---|
| VentStar Resus Neo | MP00310 | 04048675422358 |
FDA Recommendations
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.
More information, including product images of affected devices, is available at the FDA website.
