The FDA recently issued updated recommendations for the GE HealthCare EVair Compressor after testing confirmed safe levels of formaldehyde emissions with use of the device. The update provides a follow up to GE HealthCare’s Urgent Medical Device Correction notice sent to users last year.
EVair Compressors and EVair 03 (Jun-Air) Compressors provide clean, compressed air in health care settings for patients receiving ventilation support. They are typically used in conjunction with ventilator devices, such as the Carescape R860 ventilator. On December 29, 2023, GE HealthCare warned health care providers and patients about the possible risk of exposure to dangerous levels of formaldehyde when using the compressors. The company issues specific recommendations to safeguard patients from such exposure while further safety testing could be conducted.
On October 11, 2024, GE HealthCare notified users that further emissions testing has demonstrated the safety of the EVair Compressor. Given these results, the company has withdrawn last year’s recommended precautions for the EVair Compressor. As confirmed by the FDA, health care professionals can safely use the EVair Compressors in conjunction with Carescape R860 ventilators to support patients of any age, including neonates and infants. The compressors are safe for use in temperatures as high as 104 degrees Fahrenheit.
Safety teams were unable to assess the EVair 03 (Jun-Air) Compressors, so it’s unclear if formaldehyde emissions might be a safety concern with these devices. For this reason, GE HealthCare advises health care providers and patients to continue following the updated recommendations issued in December 2023 for the EVair 03 (Jun-Air) Compressors. Unlike the EVair Compressor referenced above, the EVair 03 (Jun-Air) Compressor should not be used to treat neonates and babies under the age of two. Additionally, the maximum temperature at which the EVair 03 (Jun-Air) Compressor should be used is 86 degrees Fahrenheit.
Anyone with additional questions or concerns about usage guidelines for the EVair Compressor or EVair 03 (Jun-Air) Compressor can contact GE HealthCare at 1-800-437-1171.
Patients and health care providers can report any new adverse health events related to use of GE HealthCare’s EVair Compressors or EVair 03 (Jun-Air) Compressors through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to use of GE HealthCare’s EVair Compressors or EVair 03 (Jun-Air) Compressors, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.