FDA warns of chemical exposure from compressor, ventilator combos

Editor's Note: 

General Electric (GE) EVair and EVair 03 (Jun-air) air compressors can release dangerous levels of formaldehyde when paired with Carescape R860 and Engström Carestation/Pro ventilators, the U.S. Food and Drug Administration (FDA) warned January 9.

Designed to supply the respective ventilators when wall air is not available, the two compressor models were the subject of an Urgent Medical Device Correction issued by GE HealthCare on December 29. FDA is not aware of any adverse events to date and is working with the company to conduct additional testing.

The FDA warning recommends examining the Urgent Medical Device Correction for Unique Device Identifiers (UDIs) and other information and to report any issues. Discontinuing use is particularly important for patients less than 2 years old, who are particularly susceptible to adverse effects of formaldehyde overexposure.