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Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patients

August 18, 2023 9:37 AM | Anonymous member (Administrator)

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 

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.

Showing location of part number on the bottom of the Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators

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: 

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.

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Texas Medical Equipment Providers Association

PO Box 371140, El Paso, TX 79937-1140

texmep.office@gmail.com

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