In June of 2021, Philips discovered potential health risks related to the PE-PUR (polyester based polyurethane) foam in certain versions of their CPAP, BiPAP, and other mechanical airway pressure ventilation devices. This discovery prompted them to issue a recall notification throughout the United States regarding the affected machines. In this article, we will walk you through the potential risks indicated in the recall as well as what you should do if you believe that you were affected by the harmful chemical exposure related to these devices.
Which Devices Were Recalled?
According to this FDA webpage, there have been a number of recalled Philips CPAP, BiPAP, and other medical ventilator devices which were manufactured between 2009 and April of 2021. These machines include:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
In addition to these devices, Philips has also recalled some Trilogy Evo ventilators that were distributed from April 15, 2021, to May 24, 2021. The FDA has labeled this as a Class I recall, which classifies as the most serious type of recall, for devices they conside
This part of the recall includes Trilogy Evo ventilators with the following model numbers:
- KR2110X15B (not distributed within the U.S.)
In addition to the listed ventilator devices, the recall includes repair kit assembly and lot numbers:
- Part number 1135257
- Lot numbers between 210414 and 210524
For more information regarding your Trilogy Evo ventilator, you should refer to the official list of serial numbers given in the FDA’s Class I Device Recall Trilogy Evo document.
What Makes These Devices Harmful?
Most CPAP, BiPAP, and other medical ventilators rely on the use of PE-PUR foam to reduce the sound, noise, and minimize vibration from within these devices. In the case of the recalled devices, the PE-PUR foam has a tendency to break down resulting in serious injury or permanent impairment. In some cases, health care provider intervention is necessary to prevent serious injury or illness to users.
When the PE-PUR foam breaks down, it can degrade into tiny particles that can enter the air tubes of the device and potentially be inhaled or swallowed by the patient. These particles may or may not be recognizable by the user when they are being inhaled.
In equally harmful manor, the break down of this PE-PUR foam may result in a condition known as off-gassing. This happens when organic compounds within the foam itself (in liquid or solid form) are released as particulates or gases, also known as volatile organic compounds or VOCs.
There are certain conditions that can cause PE-PUR to break down, exposing the user to off-gassing or inhaling harmful particulates. These conditions include exposure to hot or humid conditions, such as summer weather. Other factors that can worsen or accelerate the breakdown of PE-PUR foam include using cleaning methods that are not recommended by the manufacturer, including ozone cleaning.
What to Do If Your Philips Ventilator Was Recalled?
If an official notice that your Philips medical ventilation device was recalled has been posted, you have a few options for how to proceed. The first step is to call your doctor to discuss how your treatment will be adjusted as a result of this recall. Your doctor may advise you to stop using your recalled device or provide/recommend a different, similar device that is not listed under the recall. In some rare cases, your doctor may advise you to continue to use your recalled device.
After discussing the next steps with your doctor, you will want to register your device on the Philips recall webpage. This will also add you to a waiting list to receive an issued replacement device that is safe to use. Keep in mind that this list is continuously expanding, and you will receive your replacement device depending on when you registered.
Health Risks Associated with Using a Recalled Ventilator
There are various risks associated with using a recalled Philips ventilator. These risks depend on whether the user was exposed to the particulates from the breakdown of PE-PUR foam or inhaling the chemical off-gassing that may be released into the device’s air tubes. However, there are common symptoms that link to two types of exposure which include:
- Irritation to the skin, eyes, nose, and/or respiratory tract
- Inflammatory response - An inflammatory response is the body’s natural response to damage of the various tissues and cells. This occurs in the form of swelling and is triggered by events such as exposure to pathogens or trauma.
- Difficulty breathing, or chest pressure
- Extreme allergic reactions
In both cases, contact with the PE-PUR foam particulates or gases can greatly increase your risk of associated cancers, so it is important to pay attention to any hint of these sorts of symptoms. And as always, talk to your doctor or health care provider if you have questions.
What to Do If You’re Experiencing Health Problems Related to Recalled Ventilators
If you are experiencing health issues that you believe are associated with the Philips CPAPs, BiPAPs, or other medical ventilation devices, there are options for you. The first step is to meet with your health care provider and report the problem that you are experiencing. From there, your health care provider will evaluate your symptoms and determine whether or not they are associated with the complications of PE-PUR foam. If they are, you should report the issue to Philips via the Voluntary Recall Registry, and to the FDA through the FDA’s MedWatch Voluntary Reporting Form.
Our law firm is constantly investigating these defective devices and the number of symptoms, including cancer, they create. Our caring, knowledgeable, and supportive staff of attorneys and professionals are available to assist you and provide a free consultation at any time through your process. If you believe that you have been affected by any of the devices listed by this Philips recall, start by calling us at (412) 281-3000 or toll free at 1-888-MEDMAL1 (1-888-633-6251).