EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

UDI/DI ********, Serial Numbers: CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, CBCU00559

GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to consignees on 12/29/2023. The notice explained the safety issue with the device and requested the following actions be taken: GE HealthCare recommends that the EVair and EVair 03 (Jun-Air) compressors are not used to supply air to ventilators for neonatal and infant patients (0-2 years of age). Since the elevated levels of formaldehyde are observed when the compressors are used at higher room temperatures, GE HealthCare is also lowering the maximum room air temperature for operation of the compressors from 40oC (104oF) to 30oC (86oF). Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Retain this document and the Addendum to the user instructions for your records. Please keep a copy of the Addendum available near the areas where the compressors are used. GE sent an updated communication to consignees on 10/11/2024 stating the following: EVair Compressors: The recommended actions indicated in the previous letter for EVair Compressors no longer apply, as such: 1. The EVair Compressors can be used to supply air to CARESCAPE R860 ventilators for all patient populations, including neonatal and infant patients (0-2 years of age). 2. The EVair Compressor can be used in a room with maximum air temperature of 40oC (104F). EVair 03 (Jun-Air) Compressors: For the EVair 03 (Jun-Air) compressors (at End of Service Support): If you choose to continue to use these, the instructions in the 12/29/2023 letter continue to apply: 1. GE HealthCare recommends that the EVair 03 (Jun-Air) compressors are not used to supply air to ventilators for neonatal and infant patients (0-2 years of age). 2. GE HealthCare recommends that these compressors are used at a maximum room air temperature of 30oC (86oF). Contact for questions/concerns: GE HealthCare Service at 1-800-437-1171 or your local Service Representative.