Second CPAP Machine Recall Raises Concerns About Philips Respironics

Second CPAP Machine Recall Raises Concerns About Philips Respironics

Millions of Americans use continuous positive airway pressure (CPAP) machines to manage their sleep apnea and avoid going into respiratory distress at night, One of the largest manufacturers of CPAP machines, Philips Respironics, issued a massive recall of CPAP and BiPAP machines in 2021 Following this, Philips Respironics supposedly fixed the defects and returned the breathing machines. 

However, when the CPAP machines were sent back to customers, a programming error compromised critical settings and rendered some of the machines ineffective. This leaves CPAP users vulnerable to serious injury or death. CPAP users who have received faulty machines from Philips Respironics should speak with a product liability attorney to learn more about their legal options. A skilled product liability lawyer will be able to help you hold Philips Respironics accountable for their negligence in a CPAP machine lawsuit.

CPAP Machines Were Originally Recalled For Flawed Design With Disintegrating Foam

CPAP machines are designed to regulate airflow for people with sleep apnea, a chronic condition where breathing may stop and start during sleep. CPAP users raised concerns to Philips Respironics after finding black particles in their masks, which turned out to be small pieces of polyester-based polyurethane (PE-PUR) foam.

The foam’s purpose was to mitigate the noise produced by the machine. However, the design of the CPAP and BiPAP machines was such that the foam was prone to break down in the naturally humid environment created by the proper use of the machine. As a result, toxic chemicals were released into the mask as foam particles, which were then inhaled by the user. CPAP users reported a number of injuries, including:

The FDA issued a Class I recall, which is reserved for defective products that can lead to death or serious injury. If you are experiencing health issues that you believe may be related to a defect or a programming error in your CPAP machine, you should seek medical assistance as soon as possible. Not only are treatments generally more effective the sooner they are applied, but a record that you sought medical care is critical to protecting your future claim. This action prevents representatives of the defendants from claiming that you allowed your condition to worsen in order to get more compensation, which would jeopardize your settlement.

Philips Respironics’ Attempt to Rectify CPAP Defects Causes Machine Malfunctions

At least 124 deaths have been attributed to the PE-PUR foam defect. Other CPAP users have sustained extensive damages in the form of medical bills, lost wages, and pain and suffering. Philips Respironics has attempted to solve the issue with the disintegrating foam, but in turn, they have done more damage.

During the first recall, CPAP users were instructed to return their machines so that they could be adjusted. When they were redistributed, the serial numbers were applied incorrectly, meaning that the setting for individual machines may be affected. CPAP and BiPAP machines may operate according to the incorrect prescription settings, use factory default settings, or fail to operate. Based on reports from CPAP users and evidence of malfunctioning devices, the FDA has issued a second round of recalls.

The models impacted include 1,099 Philips Respironics DreamStation 1 (Uno Remediated Devices): 

  • REP DreamStation Auto CPAP Recert
  • DreamStation Auto
  • FR REP DreamStation Auto BiPAP, DOM-RECRT
  • REP DreamStation Auto CPAP, DOM – RECRT

Many people with sleep apnea rely on CPAP breathing machines to get the sleep they need and avoid suffocating, so it is critical that the proper settings are applied. Injuries caused by defective CPAP and BiPAP machines include respiratory failure, heart failure, serious injury, or death. CPAP users who have been injured as a result of Philips Respironics’ faulty machines may sustain significant physical, financial, and emotional losses. 

Recovering Damages in a CPAP Machine Lawsuit

Plaintiffs in the CPAP machine lawsuits claim that they have been unfairly burdened with damages as a result of Philips Respironics' continued negligence. Compensatory damages allow them a way to obtain financial relief for monetary, physical, and emotional losses. CPAP users may seek reimbursement for economic and non-economic damages.

 Economic damages compensate plaintiffs for losses with a monetary value. Additionally, the personal injury process acknowledges that injuries can have invisible consequences, such as emotional distress, and allows plaintiffs to pursue compensation for non-economic damages.

Examples of Damages in a CPAP Machine Lawsuit:

  • Medical bills
    • Lab tests
    • Imaging
    • Medication 
    • Hospital stays
  • Job-related losses
    • Lost wages
    • Missed promotions
    • Reduced earning capacity
  • Cost of the CPAP machine
  • Pain and suffering
  • Wrongful death
    • Loss of consortium
    • Loss of services and support
    • Loss of parental guidance and instruction
    • Funeral and burial expenses

Product Liability Claims Seek Compensation for Philips Respironics Negligence 

This second recall confirms a dangerous pattern of negligence displayed by Philips Respironics. Not only did they manufacture a product with a major design flaw, but it also appears that the company was aware of the issue with the PE-PUR foam for 6 years before they issued the 2021 recall. Now, they appear to be incapable of correcting the original defect, which leaves CPAP users in danger of serious injury or death. 

This history of negligence may provide plaintiffs with the evidence they need to establish liability and recover the compensation they deserve for damages like lost wages, medical bills, and emotional distress. Plaintiffs will still need to demonstrate that Philips Respironics owed them a duty of care and that the defective CPAP machine caused their injury, which resulted in their damages.

If you have received a defective CPAP machine after submitting it for repair, you should seek out the legal advice of a product liability lawyer to help establish liability, determine what your claim is worth, and Not only will they have the resources you need to take on an established company like Philips Respironics, they will also have the skills necessary to negotiate for the maximum compensation possible for your CPAP machine claim.


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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