Some Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Again

On December 22, 2022, the U.S. Food and Drug Administration (FDA) issued a recall announcement concerning "reworked" Philips Respironics Trilogy 100/200 Ventilators.

The FDA is providing more information to caregivers, patients, and health care providers concerning two new issues concerning recently reworked Philips Respironics Trilogy 100 and Trilogy 200 ventilators. The safety announcement states that these Philips Trilogy 100 and Trilogy 200 ventilators had been previously recalled in June of 2021 due to the polyester-based polyurethane (PE-PUR) sound abatement foam breaking down and releasing toxic fumes and particles. The two recent problems include:

1. The replacement silicone and sound abatement foam can separate due to adhesive failure moving and blocking the patient's airway, causing reduced airflow in the ventilator. Should the device's alarm sound and not acted upon, the patient could experience asphyxia, hypoxemia, or hypoventilation leading to brain damage or death. Philips BiPAP and CPAP breathing machines that have been reworked or replaced due to the June 2021 recall are not affected by this silicone foam adhesion issue because the defective adhesive was not used on the reworked or replaced CPAP and BiPAP machines.
2. Philips noticed residual PE‐PUR sound abatement foam in several reworked Trilogy 100 and Trilogy 200 ventilators that were sent back to customers. Exposure to PE-PUR foam can cause health risks, leading to injury, disease, and permanent impairment.

The Potential Health Risks from PE-PUR Foam

PE-PUR Foam is a sound-deadening product used on 5 million devices. The PE-PUR Foam can degrade, causing patients to inhale or swallow toxic, black pieces. The toxic particles can be too small to be seen in the air tubes or breathing masks. These particles release chemicals, such as Volatile Organic Compounds (VOCs) into the device's breathing tubes and can be inhaled by the patient.

The risks of being exposed to these PE-PUR foam particulates include:

• Asthma
• Inflammatory response
• Irritation to the eyes, skin, respiratory tract, and nose
• Headaches
• Cancer in organs, such as the liver and kidneys

The possible risks of inhaling these PE-PUR foam particles include:

• Allergic reaction
• Dizziness
• Headache
• Hypersensitivity reaction
• Immune system reaction
• Irritation in the respiratory tract, skin, eyes, and nose
• Nausea or vomiting
• Toxic and cancer-causing effects

In 2021, the FDA received additional information that was not previously released to the FDA concerning silicone-based foam safety testing. Philips was required to perform similar testing, as required by the FDA, on its devices that were to be sold in the United States. The FDA ordered Philips to retain an independent laboratory to test for potential safety risks potentially posed by the silicone-based foam. 

The FDA is not recommending that customers who had their breathing machines fixed during the 2021 recall discontinue the use of their CPAP or BiPAP breathing machines. The FDA drew this advisement after performing a benefit-risk assessment. At this time, the FDA has determined that stopping the use of one of these breathing devices could be more dangerous to a patient's health. The results of the independent testing will help the FDA decide if the silicone-based foam used in the repaired Philips CPAPs, BiPAPs, and ventilators pose any health risks to customers. The FDA will report those findings in a future safety notice. 

Philips Trilogy ventilators are used to supply breathing aid to adult and pediatric patients. These ventilators are used to mechanically assist or control a patient's breathing by furnishing a predetermined percentage of oxygen. Trilogy ventilators are used in both healthcare and in-home settings. Do not change or stop ventilator use until after talking to your doctor. 

Did you or a loved one sustain harmed due to a recalled Philips breathing machine? Protect your legal rights by calling Montlick Injury Attorneys Nationwide, 24/7, at 1-800-LAW-NEED (1-800-529-6333), or simply dial #WIN (#946) from your mobile phone or use our Free 24-hour live chat. Our Product Liability Lawyers are ready to listen to you, understand your situation, and advise you. View our reviews to read what our clients say about our commitment to exceptional service.

Source:https://www.fda.gov/medical-devices/safety-communications/certain-reworked-philips-respironics-trilogy-100200-ventilators-recalled-due-potential-silicone-foam