Contamination Risks Prompt Latest Philips Ventilator Recall

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The U.S. Food and Drug Administration has issued a Class 1 recall for certain Philips ventilators that have the potential to cause serious injury or death.

More than 70,000 Philips Trilogy ventilators are being recalled due to the possibility of debris accumulating in the machines’ breathing tubes. That debris has the potential to cause life-threatening injuries.

This recall covers the Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal devices. The same ventilators were recalled in March, but the recall has been given a Class 1 designation by the FDA after at least one death, two injuries and 542 complaints linked to the devices. This is the latest in a string of Philips recalls covering respiratory assistance devices.

In June 2021, Philips issued a large recall for certain CPAP machines, BiPAP machines and ventilators due to health risks. The polyester-based polyurethane foam in the devices has the potential to break down and then become inhaled or swallowed by users.

By the end of 2022, the FDA had received more than 98,000 reports of side effects connected to the breakdown of foam in the machines. There were 346 deaths related to the issue, along with several reports of other serious effects such as respiratory problems, cancer, chest pain and pneumonia.

Thousands of lawsuits were filed against Philips by people using the recalled devices to treat sleep apnea. The lawsuits claim Philips made defective machines that put people at risk. As of July, there were 673 cases still pending in multidistrict litigation. Bellwether test trials may begin as soon as 2024.

Being exposed to dirt or dust for long periods of time can lead to a buildup that may block Trilogy ventilator air vents, causing a decrease in the amount of air pressure the devices produce. This could mean not enough oxygen for patients or a buildup of carbon dioxide, both of which can lead to death or serious injury. There are several actions that can be taken to avoid any potential risks from the devices:

Prevent any accumulation of debris on the machine flow sensor:

Detect any changes in therapy:

Users may contact their local Philips representative or Philips Respironics customer service at 1-800-345-6443. Hospital customers can call 1-800-722-9377. More information on the Class 1 recall and a searchable device recall database can be found on the FDA’s website.

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