React Health is removing certain VOCSN V+Pro units due to a potential oxygen leak condition that may lead to out of specification FiO2 delivery prior to or during ventilation.
Ventec, doing business as React Health, has issued a letter to affected customers recommending certain VOCSN V+Pro units be removed from where they are used or sold due to a manufacturing process deviation that may result in an undetected oxygen leak condition, according to an FDA alert.
Due to a manufacturing test configuration error, certain devices may not have been evaluated under all intended high-pressure conditions during production testing, the FDA reports. As a result, an oxygen leak condition could occur that may lead to out of specification FiO₂ delivery prior to or during ventilation, according to the FDA.
If an oxygen leak occurs, delivered FiO₂ may be reduced below intended levels. In oxygen-enriched environments, a leak could also increase fire risk, according to the FDA. These conditions could potentially result in serious patient injury or death, the FDA warns.
The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. It may be used in invasive and noninvasive applications. The VOCSN V+Pro device includes functions of V (ventilation) only with external high- and low-pressure oxygen capability.
Affected Products
| Device Name | Catalog Number | UDI-DI |
|---|---|---|
| V+Pro Package | PRT-01198-000 | 00855573007914 |
| V+Pro Unit | PRT-01185-000 | 00855573007877 |
FDA Recommendations
Identify and stop use of affected devices. Use a non-affected ventilator for patient support.
On March 23, React Health sent all affected customers a letter recommending the following actions:
- Immediately discontinue use of affected VOCSN V+Pro.
- Inspect current stock, quarantine/segregate any unused affected products, remove affected devices from clinical service and segregate to prevent further use.
- Use a non-affected ventilator for patient support.
- If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification.
