In June 2021, the Dutch company Royal Philips (commonly known as Philips) issued a recall of millions of ventilators and sleep apnea devices after uncovering that the sound abatement foam is prone to degradation and inhalation.
Polyester-based polyurethane (PE-PUR) sound abatement foam is used in millions of Philips ventilators and sleep apnea devices. The foam is used to dampen the machine’s sound. However, the recall notice warns that the foam can degrade and enter the device’s air pathway system. Inhaling and ingesting the degraded foam particles or exposure to gases released by the degrading foam may be toxic and carry carcinogenic risks.
What are the Health Risks?
The PE-PUR foam can degrade into particles that can then enter the device’s air pathway and may also emit gas chemicals (chemical emissions). The foam’s degradation can be exacerbated by unapproved cleaning methods and exposure to high heat and high humidity environments.
If this occurs, the foam particles or chemicals emitted by the foam can be ingested or inhaled by the user and may cause the following health problems:
Health Risks of Exposure to Sound Abatement Foam Degradation:
- Headache
- Irritation
- Inflammation
- Respiratory issues
- Possible toxic and carcinogenic effects
Health Risks of Chemical Exposure to Off-Gassing (Chemical Emissions):
- Headache
- Irritation
- Hypersensitivity
- Nausea
- Vomiting
- Possible toxic and carcinogenic effects
Philips’ Response
Philips’ CEO, Frans van Houten, commented on the recall: “We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety. In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”
Ventilator and Sleep Apnea Devices Included in Recall
It’s estimated that three to four million devices globally are affected and over half of those devices were sold in the United States. The U.S. Food and Drug Administration (FDA) issued a notice reporting Philips’ voluntary recall to warn users.
The recall included millions of units of Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices.
Philips spokesman Steven Klink said that 80% of the recalled devices are sleep apnea devices(Continuous Positive Airway Pressure (CPAP) machines) and the other 20% were ventilators.
Below is a full list of the recalled devices:
- E30 (Emergency Use Authorization)
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C SEries ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- SystemOne (Q series)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- A-Series BiPAP V30 Auto Ventilator
What Should Patients Do If They Use a Recalled Ventilator or Sleep Apnea Device?
Philips advised patients who use affected BiLevel PAP and CPAP devices to stop using the device and consult their healthcare provider regarding the best alternative. However, if patients do not have alternatives, Philips recommended consulting with a healthcare provider to weigh the benefits and risks of continuing to use the affected device.
However, patients who are using an affected Philips life-sustaining mechanical ventilator device were told not to stop using the device until they have spoken with their healthcare provider.
What is Sleep Apnea?
Sleep apnea is a very common condition, especially among older adults. It occurs when the upper airway becomes blocked during sleep which reduces or stops airflow. Mechanical devices such as CPAP machines are used to treat sleep apnea by pumping air through a tube into a mask worn by the person suffering from sleep apnea.
How GoldenbergLaw Can Help You
When you use medical devices, you trust that they are going to work and keep you safe. It is terrifying to realize that a device you thought was going to protect you may actually harm you. If you or a loved one was harmed by a defective Philips sleep apnea machine, contact the Defective Medical Device Attorneys at GoldenbergLaw today. We have more than 35 years of experience, knowledge, and compassion to provide you the Gold standard of advocacy.