In June 2021, Philips Respironics recalled certain ventilators, BiPAP (bi-level positive airway pressure), and CPAP (continuous positive airway pressure) machines due to potential health risks. The U.S. Food and Drug Administration (FDA) warned that the foam inside the recalled sleep apnea machines could break down resulting in users breathing or swallowing small pieces of foam. This could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury.
Since Philips issued the recall, the FDA has received over 105,000 medical device reports, including 385 deaths, associated with the PE-PUR foam breakdown or suspected foam breakdown.
Recalled Ventilator, BiPAP, and CPAP Machine Side Effects
Since June 2021, the FDA has received a continuous stream of mandatory medical device reports from Philips and voluntary reports from health professionals, customers, and patients. These reports are one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Here are some of the injuries associated with the recalled breathing machines:
- Death
- Cancer
- Pneumonia
- Asthma
- Other respiratory problems
- Infection
- Headache
- Cough
- Dyspnea (difficulty breathing)
- Dizziness
- Nodules
- Chest pain
Why Were Philips Respironics Breathing Machines Recalled?
Philips Respironics issued the recall on certain ventilators, BiPAP, and CPAP machines after discovering that the polyester-based polyurethane (PE-PUR) foam used in the devices to lessen noise and vibration was breaking down into small, black pieces of foam that could be inhaled or swallowed by users. Users were also at risk of inhaling or swallowing chemicals released from this breakdown.
Philips advised users of affected BiPAP and CPAP machines and caregivers to talk with their healthcare provider about other treatments or whether the benefits of using the defective machines outweigh the risks. Caregivers of ventilator users and healthcare facilities were advised not to stop using or change use until they talk with their healthcare provider, as alternative options for therapy may not exist or may be severely limited for some patients.
As part of its actions, the FDA initiated on-site inspections of Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements. The agency also said it was analyzing medical device reports related to the affected devices from 2009 to 2021 for ones that could be related to the PE-PUR foam breakdown issue.
Meanwhile, Philips announced that it would repair and replace affected devices and return them to customers.
What CPAP Machines Were Recalled?
Since June 2021, Philips Respironics has recalled over 15 million CPAP and BiPAP sleep apnea machines and ventilators due to the breakdown of its Pe-PUR foam through two separate recalls:
June 30, 2021 Recall
Philips Respironics recalled all model names and serial numbers of the following devices manufactured between 2009 and April 26, 2021:
CPAP and BiPAP Devices
Continuous, Minimum Ventilatory Support, Facility Use
- E30 (Emergency Use Authorization)
Continuous, Non-Life Supporting
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-series ASV
- C-Series S.T and AVAPS
- OmniLab Advanced+
Noncontinuous
- SystemOne (Q-Series)
- DreamStation
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
Ventilators
Continuous Ventilator
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
- A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting
- A-Series BiPAP A40
- A-Series BiPAP A30
December 22, 2022 Recall
Philips Respironics repaired some of its recalled ventilators, BiPAP, and CPAP machines and returned them to customers. On December 22, 2022, the company issued a recall for certain previously recalled, reworked, and reissued Trilogy 100 and Trilogy 200 ventilators due to two concerning issues:
- The silicone sound abatement foam installed to replace the defective PE-PUR foam, may separate from the plastic backing, move, and block the airpath. This would cause a reduction in air flow in the ventilator which could trigger the device’s alarm. If the alarm isn’t recognized and acted upon promptly, the patient could experience asphyxia, hypoventilation, or hypoxemia — all of which can be life-threatening.
- Additionally, Philips observed residual PE-PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Further exposure to PE-PUR foam may cause potential health risks resulting in serious injury, cause permanent impairment, and require medical intervention.
What Were the Recalled CPAP Machines Used For?
The recalled Philips Respironics devices are used to help breathing. Philips recalled three types of breathing machines — continuous ventilators, BiPAP, and CPAP:
- A continuous ventilator mechanically controls or helps patients’ breathing while delivering a set amount of oxygen. Continuous ventilators are often used with patients in intensive care units.
- A BiPAP machine pumps air of varying pressure into the airways of the lungs. BiPAP machines use a higher pressure when you breathe in and a lower pressure when you breathe out. These devices are prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
- A CPAP machine keeps your airway open by providing a stream of air at a continuous pressure through a mask. CPAP machines are often prescribed to people with obstructive sleep apnea to keep their airways open while they sleep.
Seek Compensation from a Sleep Apnea Machine Lawsuit
People who used the recalled breathing machines, or surviving family members of users who developed cancer or a respiratory illness, may be able to join the fast-growing Recalled CPAP machines multi-district litigation (MDL). This nationwide CPAP lawsuit allows those harmed by these devices to seek compensation for their medical bills, pain and suffering, and other losses. These cases can be complex, and important deadlines apply. It’s important to talk with a lawyer to see if you qualify for a CPAP lawsuit.
Harmed by a Recalled CPAP Machine? Contact an Experienced Lawyer Today
If you or a loved one suffered harm from a Philips Respironics recalled CPAP, BiPAP, or ventilator, you deserve to be compensated by the manufacturer for your medical bills, pain and suffering, and other damages. If you are considering filing a claim, having a lawyer with experience handling complex litigation cases can significantly improve your chances of obtaining a favorable outcome.
The mass tort lawyers at Lawsuit Legal News have years of experience helping people like you seek justice against the companies that harmed them. Contact us today at 866-467-0943 or complete our online contact form for a free consultation, and let’s discuss your case.