Philips Ventilator Recall Issued Due to Aerosol Deposits From In-Line Nebulizer Placements

Federal regulators have determined that problems linked to the placement of in-line nebulizers with some Philips ventilators pose a risk of severe injury or death for patients, who may receive too little or too much oxygen.

In early October, Philips Respironics issued updated instructions for its Trilogy Evo line of ventilators, indicating that nebulized aerosol deposits may accumulate over time, permanently impacting the device’s internal flow sensor. However, on November 19, the U.S. Food and Drug Administration (FDA) announced that it considers the action a Philips ventilator recall, giving it a class I designation, following reports of at least four patient injuries.

The issue affects Trilogy EVO, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo and LifeVent EVO2 ventilators. The aerosol deposits can build up when in-line nebulizers are used in certain locations, which can lead to inaccurate flow measurements. This may cause patients to receive the wrong amount of oxygen therapy.

The FDA warns these problems can result in a number of serious adverse health complications, including respiratory discomfort, lung damage, oxygen over-delivery, low oxygen saturation, shortness of breath, therapy delays and deaths.

Philips Ventilator Instructions Updated

Philips first warned its home care and hospital customers about the potential problems in an Urgent Medical Device Correction letter, which was issued on October 7, 2024.

The updated instructions called for users of the affected ventilators to make sure that specific alarms are set appropriately for patients, especially if the devices have historically been used with an in-line nebulizer. The letter urged users to make sure an alternate source of ventilation is available, in case the affected ventilator ceases to function.

The letter also included additional instructions when using an FiO2 oxygen concentration setting, recommending providers use continuous pulse oximetry monitoring, make sure to use an external FiO2 analyzer in specific patient cases, and switch to an alternative ventilator if one is not available.

Home care customers with questions about the affected devices can contact Philips at 1-800-345-6443, option 4, then option 5. Hospital customers can call 1-800-722-9377, option 2.

Philips Breathing Device Problems

This is the latest in a series of recalls issued in recent years involving problems with breathing assistance devices sold by Philips, which has faced sharp criticism from regulators over its handling of issues with DreamStation CPAP, BiPap and other machines that were removed from the market in 2021, after it was discovered that toxic sound abatement foam inside millions of devices may breakdown and release toxic particles into the air pathways.

As a result of problems linked to that earlier recall, thousands of Philips CPAP lawsuits have been filed by former users left with severe lung damage, respiratory injuries and other injuries, and the FDA has identified serious deficiencies in the company’s recall and repair program, which has further increased the risks faced by owners of the machines.

The FDA repeatedly warned that the company was failing to properly repair and replace the recalled units, announcing a consent decree earlier this year that barred Philips from manufacturing and distributing CPAP and other breathing assistance devices in the U.S. until the company shows it can meet requirements set by federal regulators.

In September 2023, Philips announced it will pay at least $445 million in a CPAP recall class action settlement to individuals who bought, rented or leased one of the impacted devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines.

To resolve personal injury and wrongful death lawsuits, the company also announced a $1.1 billion Philips CPAP recall settlement agreement in April 2023, effectively ending litigation over problems linked to the defective sound abatement foam at issue in the 2021 recall.

In addition, the company has agreed to pay $25 million to resolve a class action lawsuit over the need for patients who once used the recalled devices to receive medical monitoring. A federal judge granted final approval to the Philips CPAP medical monitoring settlement last week.