Philips Respironics, Inc. has issued an Urgent Medical Device Correction for their series of Trilogy Evo ventilators due to concerns of aerosol deposits on the flow sensor when using in-line nebulizers. According to the FDA, the correction involves a field safety notice with updated guidelines and a list of precautions for customers using the ventilators.
Issued on October 7th, the correction applies to the Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators. While internal testing at Philips Respironics raised concerns about the potential for the accumulation of aerosol deposits on the flow sensor, at this time, the company has not received any reports of injury or death related to this issue.
The Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators are portable ventilation devices used to provide respiratory support to patients. Some patients use in-line nebulizers in conjunction with the ventilators to “convert therapeutic liquids (such as medication/saline solutions) into an aerosol to treat different respiratory symptoms.” Philips Respironics say that the aerosols generated by such a nebulizer could accumulate on the flow sensor for the ventilator and cause “inaccurate flow measurements.” These inaccuracies could cause a variety of issues, including delay of therapy if the machine were to power off or a delivery of too much or too little air or oxygen if the sensor were to generate an inaccurate reading. These issues, in turn, can cause potentially dangerous complications for patients, such as injury to the lungs, “low oxygen saturation,” or shallow breathing.
To prevent the negative outcomes listed above, Phillips Respironics urges users to take the following precautions when using the Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators:
- Monitor patients with a pulse oximeter to ensure they are receiving enough oxygen.
- Use a different ventilator if and when an external FiO2 analyzer is unavailable.
- Always have an alternate ventilator available in case of device failure.
- Adhere to the “visual instructions” provided in the safety notice regarding placement of in-line nebulizers to decrease the chances of aerosol accumulation.
- Use an alternate ventilation device when using an in-line nebulizer with any of the specific medications listed in the field safety notice.
Anyone with questions about this Urgent Medical Device Correction can contact Customer Service for Philips Respironics at 1-800-345-6443, option 4, then option 5 (for DME and Homecare customers) or 1-800-722-9377, option 2 (for patients in a hospital setting).
Patients and health care providers can report any new adverse health events related to the Neo-Tee T-Piece Resuscitator through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an adverse health outcome caused by a Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, or Trilogy EV300 ventilator, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent further injury to patients receiving respiratory support. Our experienced attorneys at TruLaw are prepared to learn about your story and help you build a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.