Breas has issued an Urgent Medical Device Correction to notify you of a potential defect with certain Vivo 45 units.
In summary, when certain units are set to extremely high temperatures and low flow rates, a harmful gas may be emitted.
Both Breas and the FDA have stated that the chances of harmful exposure as a result of this defect are minimal. And there are precautions to be taken to further prevent dangerous circumstances from arising.
Patients are advised by Breas to avoid using the device in high ambient temperature settings. The recommended safe operating ambient temperatures range from 86 degrees Fahrenheit to 104 degrees Fahrenheit.
As previously stated, only specific units have been identified as being at risk of this defect. See the affected units below:
Please note, Wave patients utilizing a home ventilator are typically set to significantly higher flow rates, and are therefore unlikely to have their device set to an ambient temperature over 100 degrees. We are confident that the chances of our patients being affected by this situation are very low.
That being said, out of an abundance of caution, we do encourage everyone utilizing a Vivo 45 ventilator to review the full Device Correction statement from Breas. If you are using using equipment with an affected serial number or manufacturing date, and your child’s current temperature settings do not fall within the safe operating ambient temperature range, please contact us. A member of our team will be happy to assist you.
You can view the full Breas Device Correction statement on their website. Click the button below to do so.
You may also view and download the full statement in PDF format below. If you do not initially see this PDF document, or you receive an error message, please try refreshing the page.