The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product 

• Product Name: Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal
• Product Models and Serial Numbers: See Medical Device Recall Database
  • Trilogy Evo O2 EV300
  • Trilogy Evo O2 and LifeVent EVO2
  • Trilogy Evo, Garbin Evo and Aeris Evo
  • Trilogy Evo Universal Ventilator
• Distribution Dates: March 26, 2019 to March 22, 2023
• Devices Recalled in the U.S.: 73,000
• Date Initiated by Firm: March 29, 2023

Device Use

Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide continuous positive airway pressure (CPAP) and intermittent positive airway pressure breathing support for people who need mechanical ventilation. They are intended for pediatric through adult patients weighing at least 2.5 kg and are used in hospitals and health care settings and for patient nonemergency transport. The Trilogy EV300 and Trilogy Evo may also be used by people requiring mechanical ventilation in their homes.  

Reason for Recall 

Philips is recalling Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt from the environment in the air path of some devices. Extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the right amount of air pressure, or air volume/flow. 

If the ventilator fails to provide the right level of breathing support, patients may not receive enough oxygen (hypoventilation) and may experience a build-up of carbon dioxide or other gas pressure, which can lead to serious injury or death. 

Philips has received 542 reports about this issue. There are currently two reported injuries and one death. 

Who May be Affected 

• People who receive breathing support from the affected Trilogy Evo, Evo O2, EV300, and Evo Universal machines. 
• Health care providers and in-home caregivers who provide care for patients using Trilogy Evo, Evo O2, EV300, and Evo Universal for breathing support. 

What to Do 

On April 17, 2023, Philips sent affected customers and patients an Important Product Notice with the following actions: 

How to identify affected products

• Locate the part number on the bottom of the device and verify it against the impacted part numbers noted in the letter.

Actions for users to prevent risk to patients

• Prevent accumulation of debris on the machine flow sensor:

  • Use the Philips approved particulate filter, which prevents a significant majority of airborne aerosols and particulate from entering the device. This filter is now required. 
  • Replace the filter between patients as indicated in the Instructions for Use. 
  • Use the air-inlet filter as indicated in the Instructions for Use.
    • Note: Installation of the particulate filter does not require a change to therapy settings. 
• Detect changes in therapy.
  • Set appropriate alarms based on ventilation mode, such as Low Tidal Volume, Low Minute Ventilation, Low Inspiratory Pressure, and High Inspiratory Pressure.
    • The Check Proximal Pressure and External Flow Sensor Failed alarms can also alert the user to this issue—these are non-settable alarms. 
  • Inlet Filter Blocked alarm will sound if therapy is reduced due to filter blockage. User must rinse the air-inlet filter and replace the particulate filter if this occurs.
  • Follow instructions for any alarm, especially Ventilator Service Required or Ventilator Inoperative. 
  • Use alternative ventilation equipment if the situation cannot be resolved. 
  • Make sure ventilator-dependent patients have access to alternative ventilation equipment, such as a back-up ventilator or manual resuscitator. 

Contact Information 

For questions and support, contact your local Philips representative or Philips Respironics Customer Service.   

• Home care customers: 1-800-345-6443
• Hospital customers: 1-800-722-9377

Additional Resources: 

• Medical Device Recall Database entry: Trilogy Evo O2 EV300

• Medical Device Recall Database entry: Trilogy Evo O2 And LifeVent EVO2
• Medical Device Recall Database entry: Trilogy Evo, Garbin Evo, And Aeris Evo
• Medical Device Recall Database entry: Trilogy Evo Universal Ventilator
• FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.

Source

The nationwide durable medical equipment (DME) provider continues to advocate for making items like diapers and breast pumps tax-free on a state by state basis

Aeroflow Healthcare, a nationwide provider of durable medical equipment through insurance, today celebrated the passage of Texas SB 379 after directly advocating and lobbying for the change in the state. This piece of legislation will benefit hundreds of thousands of families and individuals by eliminating taxation on numerous care products such as diapers and breast pumps, starting September 1, 2023.

Aeroflow Healthcare has been active across numerous U.S. states this year to advocate for changes in accessibility to care and health supplies. The DME provider directly lobbied with the Texas House and Senate on the diaper tax elimination (HB 300), and pushed for adding breast pumps to the exemption, resulting in its inclusion in SB 379. As a result, Texas residents will now be able to obtain the following products, tax free: adult and child diapers, breast pumps, bottles, baby wipes, feminine hygiene products, maternity clothing and wound care dressing.

“We are encouraged to see SB 379 pass, yet another reflection of the work our government relations team has conducted to ensure more patients and caregivers can access medically-necessary products and resources to live a healthier life,” said Ryan Bullock, COO at Aeroflow Healthcare. “Both Texas and the recent addition of Florida this past May are two significant additions to the growing number of states our team has successfully lobbied in to enact important legislation changes. We look forward to continuing our mission of breaking down legislative barriers that currently block patients from obtaining products and care in other states.”

For over a decade, Aeroflow Healthcare has been committed to providing high-quality medical products and services to patients across the country. The passing of Texas’s HB 379 comes at a time when the provider is taking further steps to bolster their government relations efforts in order to improve equitable access to care. The recently announced program will shine a spotlight on policies at both the state and federal levels to make critical healthcare products like breast pumps and diapers more affordable, prioritizing quality of life for all.

Source: Globe Newswire