Carina (ventilator)

2023: Recall of ventilators

On August 23, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of Carina ventilators manufactured by Draeger. The use of these devices can result in harm to the health of patients.

Carina is a compact ventilator suitable for both inpatient use and patient transportation. The device is able to recognize changes in flow parameters, providing the necessary level of support and at the same time providing the patient with the opportunity to breathe independently. There are several ventilation modes, and the AutoRamp function simulates natural breathing. The integrated mixer provides an oxygen concentration of 21% to 100%.

Carina ventilator

The recall of the devices is associated with the formation of contaminants in the air path of the devices. Tests also showed the presence of polyester/polyurethane, which provokes emissions of 1,3-dichloropropane-2-ol, a potential carcinogen. The use of Carina ventilators for pediatric patients can lead to serious adverse health effects, including exposure to hazardous chemicals and the manifestation of toxic reactions. In the worst case, this can be fatal.

These devices were delivered to the American market from March 16, 2009 to October 20, 2012. Globally, Carina devices were sold from May 23, 2007 to February 3, 2022. Models with a 04048675398516 ID are subject to feedback. As of the end of August 2023, there are no reports of fatal incidents related to this problem. Medical facilities that use Carina are advised to use only a Draeger vent hose with a safety valve and a bacterial filter.^[1]

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