WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced that Breas Medical is initiating a nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing identified the potential for short-term elevated levels of formaldehyde exposure under specific conditions.
The affected devices were manufactured between February 4, 2021, and July 1, 2024, and distributed from February 12, 2021, to July 24, 2024. To date, Breas Medical has received no reports of patient injury or adverse effects related to formaldehyde exposure from the use of the Vivo 45 LS.
Short-term formaldehyde emissions can lead to adverse pulmonary or neurological effects. These may include transient, reversible airway irritation or inflammation, and airway hyperresponsiveness such as asthma in small pediatric patients, potentially necessitating additional medical intervention.
The devices can be identified by the model name on the front panel and the model and serial numbers on the back panel. They have been distributed nationwide to Durable Medical Equipment providers, distributors, and facilities.
Product Details:
- Product Type: Medical Devices
- Reason for Announcement: Potential for short-term elevated levels of formaldehyde exposure
- Company Name: Breas Medical
- Brand Name: Breas
- Product Description: Vivo 45 LS (US Version) Ventilator
Breas Medical is notifying its distributors and commercial customers via email and phone. The correction involves reducing the maximum room air temperature for device operation from 40°C (104°F) to 30°C (86°F) and pre-running new devices for 14 days before patient use. Existing end users will receive an update to the Instructions for Use (IFU).
End users and recipients should contact the provider or Breas Medical for further information on necessary corrective measures. Patients and caregivers with questions can reach Breas Medical at 1-855-436-8724, Monday through Friday, 8:00 am to 5:00 pm (Eastern Time), or via email at vivotechnicalsupport@breas.com.
Adverse reactions or quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or fax.
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