Reason for Correction Letter:

GE Healthcare states:

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 Engström 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. The amount of exposure to formaldehyde during typical clinical use and the potential risks to health from such exposure, if any, are currently unknown. However, in an unlikely scenario in which the compressors are used at the conditions described above, the formaldehyde levels may lead to adverse pulmonary affects such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness (e.g. asthma) in neonates or infants, resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support).

Compressors are optional accessories for ventilators and are only used when wall air is not available, which is not typical in most hospital settings.
GE HealthCare has not received any reports of patient injury or adverse effects related to potential exposure to formaldehyde from the use of the compressors with ventilators.

FDA’s Determination:

Component design/selection.

Recall Quantity:

Across all 3 recalls the total recall quantity is 5338.

Customer/Patient Actions:

1. 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).
2. 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).
3. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions.
4. 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.
5. Complete and return the attached acknowledgement form to Recall_FMI 34134@ge.com.

Contact Information:

If you have any questions or concerns regarding this notification, please contact GE HealthCare Service or your local Service Representative.