What You Need to Know

  • Philips issued a recall notification impacting millions of Bi-Level Positive Airway Pressure (Bi-level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices used in the US.
  • Philips warned that the polyester-based polyurethane foam component can degrade into particles and expose users to harmful chemicals causing headaches, inflammation, respiratory issues, and toxic and carcinogenic effects.
  • People injured by inhaling or ingesting the toxic foam particles may need to file an individual lawsuit to be compensated for their injuries.

If you use a Philips CPAP, BiPAP, or Ventilator to treat your sleep apnea, you may be entitled to compensation. Complete the free case review form or call 1.800.887.8029 for a free and confidential consultation.

Philips Sleep Apnea Machine Health Risks

The U.S. Food and Drug Administration issued an FDA Safety Communication warning that users of certain Philips CPAP, BiPAP, and ventilator machines may be breathing in particles known to be toxic or have a carcinogenic effect to organs, such as the kidneys and liver.

According to the FDA, Philips’ own testing identified serious potential risks associated with polyurethane foam in its Bi-level PAP, CPAP, and ventilator machines.  Specifically, a piece of foam that is used to reduce sound and vibration may break down and potentially release chemicals that are then inhaled or swallowed by the person using the device.

Philips CPAP, BiPAP, and Ventilator Injuries

Philips reports it has received several complaints “regarding the presence of black debris/particles within the airpath circuit” which may cause the following potentially serious and life-threatening injuries:

  • Cancer or carcinogenic effects
  • Kidney and liver injuries
  • Respiratory issues
  • Asthma
  • Headache
  • Irritation
  • Inflammation

Some injuries may cause permanent impairment and require medical intervention.

Instructions for Users of the Recalled Devices

Philips is providing different instructions based on whether someone is using the device for life-sustaining treatment:

For Users of life-sustaining mechanical ventilator devices

The recall notification advises patients to not discontinue or alter their prescribed therapy until they have talked to their doctor.

 

For Users of the Bi-Level PAP and CPAP devices

The recall notification advises patients to discontinue use and consult with their doctor to determine the most appropriate options for treatment.

 

Philips’ devices included in the recall notification

Zimmerman Reed is investigating the following affected devices that were included in the FDA’s Safety Communication:

CPAP and BiPap Devices

Device Type Model Name
Continuous Ventilator, Minimum Ventilatory Support, Facility Use E30
Continuous Ventilator, Non-life Supporting DreamStation ASV

DreamStation ST, AVAPS

SystemOne ASV4

C-Series ASV

C-Series S/T and AVAPS

OmniLab Advanced+

Noncontinuous Ventilator SystemOne (Q-Series)

DreamStation

DreamStation Go

Dorma 400

Dorma 500

REMstar SE Auto

 

Ventilators

Device Type Model Name
Continuous Ventilator Trilogy 100

Trilogy 200

Garbin Plus, Aeris, Lifevent

Continuous Ventilator, Minimum Ventilatory Support, Facility Use A-Series BiPAP V30 Auto
Continuous Ventilatory, Non-life Supporting A-Series BiPAP A40

A-Series BiPAP A30

 

Philips Sleep Apnea Machines in the News

July 6, 2021: Recall of Sleep Apnea Machines Leaves Many in the Lurch, and Worried, bostonglobe.com

June 15, 2021: Philips Recalls Sleep Apnea Machines, Ventilators Over Cancer Risk, usatoday.com

June 14, 2021: Philips Recalls Ventilators, Sleep Apnea Machines Due to Health Risks, reuters.com

 

CPAP Lawsuits

People injured by Philips’ sleep apnea machines and ventilator devices may be entitled to compensation. In order to receive compensation, people may need to pursue individual claims to receive compensation.

How We Can Help

If you or a loved one used a Philips CPAP, BiPAP, or Ventilator to treat your sleep apnea, you may be entitled to compensation. Complete the free case review form or call 1.800.887.8029 for a free and confidential consultation to determine if you are eligible. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.