What: Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal
Who: Philips Respironics (Philips)
Why: 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, causing blockage in the ventilator's air vents, preventing the right level of breathing support to patients, which can lead to severe injury or death.
When: The recall was initially announced on March 29, 2023.
Where: This recall affects the Philips respirators in the United States.
How customers can identify the recalled product: Customers can locate the part number on the bottom of their device and verify it against the impacted part numbers noted in the URGENT Medical Device Correction notification letter from Philips.
Earlier this year, Philips Respironics, an American medical supply company owned by Philips that specializes in products that improve respiratory functions, issued a recall for their Trilogy Evo ventilators after discovering the buildup of dust inside the ventilator could block the devices' air vents, and cause them to no longer deliver the right amount of air pressure or volume to the patient, risking severe injury or death. Due to the risk severity, the FDA has identified this as a Class I recall.
The Philips Trilogy Evo ventilators help provide continuous positive airway pressure (CPAP) and intermittent positive airway pressure breathing support for people who need mechanical ventilation. The ventilators are intended for patients ranging from pediatric to adult patients and are used in hospitals and health care settings, nonemergency transport, and for patients who receive at-home care. To date, Philips has received 542 reports about this issue, with two reported injuries and one death.
Which Ventilators Are Involved in the Philips Recall?
This recall currently affects 73,000 devices. For a complete, detailed list of all recalled Philips ventilators that include the product code information, you can head to the FDA's website here. Currently, the Philips ventilator recall consists of the following ventilator models:
- Philips Respironics Trilogy Evo
- Trilogy Evo O2
- Trilogy EV300
- Trilogy Evo Universal
What Remedies Are Available for Philips Customers?
According to the notice posted by the FDA, to help prevent the accumulation of debris on the machine flow sensor, medical providers must use the Philips-approved particulate filter, which prevents a significant majority of airborne aerosols and particulates from entering the device. This filter must be replaced between patients and monthly, as indicated in the "Instructions for Use," and is no longer optional but required. Medical providers who detect changes in therapy are required to follow certain guidelines in order to ensure the continued use of the ventilators is done in a safe manner.
Providers are to set appropriate alarms based on ventilation modes, such as Low Tidal Volume, Low Minute Ventilation, Low Inspiratory Pressure, and High Inspiratory Pressure. In the case a solution cannot be found, medical providers are required to ensure their ventilator-dependent patients have access to alternative ventilation equipment, like a backup ventilator or manual resuscitator. For more information on what steps providers should take in order to ensure the safety of their patients, they should refer to the instructions that accompany the ventilator or contact Philips Respironics Customer Service.
The recall is just the latest for Philips Respironics. In 2021, the company announced it began the process of repairing or replacing 5.5 million sleep apnea machines and respirators due to the risk of the sound abatement foam used in the machines breaking down and being inhaled by patients. At the end of 2021, the company would also recall the Trilogy Evo ventilators after discovering certain models contained the same polyester-polyurethane foam.
Then again, this past April, the FDA issued a separate recall for the Trilogy ventilators, warning that an issue with an internal sensor could lead to under-delivery of oxygen, where Philips claims it plans to fix the issues with a software update. For more information regarding what you can do to ensure you are following the proper guidelines or if you have questions, customers can contact their local Philips representative or Philips Respironics Customer Service at 1-800-345-6443 for home care or at 1-800-722-9377 for hospital customers.
If you or a loved one have suffered an injury due to the Philips ventilators or have questions concerning the recall, contact a Morgan & Morgan attorney today by completing our free, no-obligation case evaluation form.