Breas Medical, a Massachusetts-based manufacturer of medical equipment for respiratory care and sleep apnea treatment, has announced an urgent medical device correction for 8,186 Vivo 45 LS ventilator units distributed across the US.
According to the US Food and Drug Administration (FDA), internal testing revealed that the ventilators might emit elevated levels of formaldehyde under certain conditions, which could pose risks of short-term exposure.
Such exposure could result in adverse pulmonary or neurological effects, including transient airway irritation or inflammation, and potentially lead to airway hyperresponsiveness, such as asthma, particularly in small paediatric patients. This may require additional medical interventions, including bronchodilator administration, adjustments to ventilator settings, and increased ventilatory or oxygen support, said the regulator.
The affected devices were manufactured between 4 February 2021 and 1 July 2024, and distributed from 12 February 2021 to 24 July 2024.
The FDA has noted that Breas Medical has not received reports of patient injuries or adverse effects directly related to formaldehyde exposure from the Vivo 45 LS ventilators to date.
The correction affects devices identified by their model name on the front panel and the model and serial numbers on the back panel (“REF” and “SN”). These devices have been supplied nationwide to durable medical equipment providers, distributors, and healthcare facilities.
Breas Medical is said to be notifying its distributors and commercial customers via email and phone about the required corrections. The correction entails reducing the maximum operational room air temperature for the devices from 40°C (104°F) to 30°C (86°F) and mandates that new devices shipped until 24 July 2024 be pre-run for 14 days before use.
The FDA stated that existing users in the US will receive updated Instructions for Use (IFU) reflecting the correction.
The Vivo 45 LS ventilators were cleared by the FDA in 2021, under the 510(k) premarket notification process. This clearance permitted Breas Medical to market the ventilators in the US, following a review to ensure that the devices were substantially equivalent to legally marketed predicate devices.
