Datex-Ohmeda Issues Field Correction for EVair Air Compressors

Urgent Class I Recall Notice  

Datex-Ohmeda Inc. has announced a field correction for its EVair and Jun-air compressors, optional ventilator accessories designed to provide an alternative source of airflow for patient support in clinical settings where wall air is unavailable.  

Device Use 

The EVair and Jun-air compressors serve as essential components for critical care ventilators, delivering compressed medical breathing air or breathable compressed air to support patient ventilation.  

They are intended for use with specific Datex-Ohmeda critical care ventilator models, providing a vital resource in scenarios where traditional air sources (e.g. wall air) are not accessible. 

Reason for Recall  

The recall stems from elevated levels of formaldehyde emissions detected under certain conditions when these compressors are used with the CARESCAPE R860 or Engstrom Carestation/Pro ventilators.  

While no injuries or deaths have been reported, the potential adverse health consequences are concerning, particularly for newborns and infants.  

Prolonged exposure to formaldehyde emissions could lead to airway irritation or inflammation, potentially resulting in airway hyperresponsiveness in these vulnerable patients. 

Who May be Affected  

This recall impacts individuals receiving care in healthcare settings where EVair and Jun-air compressors are utilized, as well as healthcare personnel responsible for administering treatment.  

It is essential to note that the EVair compressor is not suitable for use with neonatal or infant patients aged 0 to 2 years, emphasizing the importance of targeted precautions. 

Recommended Actions

Affected customers received an Urgent Medical Device Correction on December 29, 2023, urging immediate action to mitigate potential risks. Key recommendations include: 

• Cease Use for Neonatal and Infant Patients: Discontinue the use of supply air to ventilators for patients within the age range of 0 to 2 years. 
• Temperature Control: Maintain a maximum room air temperature of 30°C (86°F) during compressor operation to minimize formaldehyde emissions. 
• Awareness and Communication: Ensure all relevant personnel within healthcare facilities are informed about the safety notification and advised actions. 
• Documentation: Retain the Urgent Medical Device Correction and the Addendum to the user instructions for record-keeping purposes, making these resources readily accessible in areas where compressors are utilized. 

Conclusion 

In conclusion, the field correction issued by Datex-Ohmeda underscores the paramount importance of patient safety in medical device usage.

By promptly adhering to the recommended actions, healthcare facilities can safeguard the well-being of patients and mitigate potential risks associated with the use of EVair and Jun-air compressors. Stay informed, stay vigilant, and prioritize patient safety above all else. 

Links 

Read the FDA recall notice here.  

Read the January 9, 2024 letter to healthcare providers for the same products here.