Many people have received recall notices from Philips Respironics about their CPAP device, BiPAP machine, or ventilator. The Food and Drug Administration (FDA) warns that there is a health risk in using these medical devices.
If you or a loved one used (or uses) a Philips medical breathing device for sleep apnea or another condition, you might have lung damage or other severe medical conditions as a result. A Florida Philips CPAP lawsuit lawyer could help you go after the compensation you deserve for the harm you suffered.
What Went Wrong in the Philips CPAP Machines
Philips used polyester polyurethane foam for more than 10 years in these medical devices. The foam was supposed to reduce vibration and noise to allow users to sleep comfortably. With usage, the polyester polyurethane foam degrades, forcing debris and toxic chemicals into the person’s airways using the machine.
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The Health Problems Associated with the Philips CPAPs
The FDA warns of these potential health risks from the polyester-based polyurethane foam used in these devices:
- The foam can break down into small black bits that get into the air tubes of the device, and the CPAP user inhales or swallows the material.
- As the foam degrades, dangerous chemicals, also called volatile organic compounds, can enter the air tubes of the device and get inhaled by the user.
- Inhaling or swallowing pieces of the foam could cause headache, inflammatory response, asthma, or toxic or cancer-causing damage to organs like the kidneys and liver.
- The foam debris can also irritate the eyes, nose, skin, and respiratory tract.
- The toxic chemicals from the foam can cause headaches, dizziness, nausea, or vomiting.
- The chemicals can also irritate the skin, nose, respiratory tract, and eyes.
- Some people might have an allergic reaction or another immune system reaction to the chemicals.
- The chemicals can also have toxic and cancer-causing effects.
The more we learn about polyester-based polyurethane foam, the more likely we will discover additional adverse health consequences.
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The History of Problems with the Philips CPAP Devices
The FDA performed inspections and investigations from August 26, 2021, through November 9, 2021. The FDA investigator’s report, dated November 9, 2021, found, among other things, that:
The Risk Analysis at Philips Respironics, Inc., Is Inadequate
Philips knew as early as 2015 about complaints from people in the field concerning polyester polyurethane foam degradation and volatile organic compound emission (toxic chemicals) in some of their ventilators, CPAPs, and BiPAP devices.
However, Philips failed to investigate, analyze the risk, or analyze the design failure in other Philips devices that contain polyester polyurethane foam.
Philips Hasn’t Initiated Procedures for Corrective or Preventive Action
Despite multiple complaints about polyester polyurethane foam degradation, the company hasn’t adequately established action systems to prevent or correct the reported damage the products cause. Philips admitted they received 1,254 complaints about foam degradation from 2014 to April 2021.
The Devices Had Known Design Problems
The design validation evaluation for the devices “did not conform to or address the user needs of the intended patient population of these ventilatory medical devices.”
Philips dismissed those issues because the devices would not harm people with normal, healthy lung tissue. The company designed these devices for people with lung and other breathing problems.
Philips Implemented Short-Term Solutions Instead of Real Fixes
Philips did not adequately establish procedures for design change before implementation. In other words, Philips created and implemented maintenance and service responses to the many complaints Philips received about foam degradation and toxic chemicals since 2015. However, the company did not adequately verify or validate that those “fixes” would cure the problems.
Philips Did Not Properly Report Their Field “Solutions” to the FDA
Philips was aware of health risks posed by their devices and took some maintenance actions intended to correct the issues but did not report these field corrections in writing to the FDA.
The report lists numerous failures by Philips to take appropriate action in response to many complaints from people in the field about problems with these medical devices.
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How to Find Out If Your CPAP Machine Is a Part of the Recall
The FDA investigator’s report stated in multiple locations that Philips is recalling more than 15 million Philips Respironics ventilator, CPAP, and BiPAP devices because of the degradation of the polyester polyurethane foam and volatile organic compound emissions (toxic chemicals).
The FDA defines medical device recalls as Class I, II, or III to indicate the relative degree of risk to the device user. The Philips recall is a Class I medical device recall. The FDA defines Class I medical device recalls as “A situation where there is a reasonable chance that a product will cause serious health problems or death.”
You can check the list of Philips CPAP and respirators that are currently part of the recall. Also, you could go to the Philips Respironics website and enter your device’s serial number. The Philips website will tell you if your device’s serial number is one of the recalled models. You will want to keep in mind that even if your device is not one of the recalled models, that situation could change in the future.
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Which Philips CPAPs and Respirators Got Recalled – So Far
It could be helpful for you to see a quick list from the FDA of the Philips Respironics recalled models. Please be aware that this list could get changed at any time.
Here are some of the current recalled Philips Respironics CPAPs, BiPAPs, and ventilators, all of which got manufactured between 2009 and April 26, 2021:
- DreamStation ASV; DreamStation ST, AVAPS; DreamStation; DreamStation Go
- SystemOne ASV4; SystemOne (Q-Series)
- C-Series ASV; C-Series S/T and AVAPS
- Dorma 400; Dorma 500
- OmniLab Advanced+
- REMstar SE Auto
- Trilogy 100; Trilogy 200
- Garbin Plus; Aeris; LifeVent
- A-Series BiPAP A30; A-Series BiPAP A40
Philips also recalled several models used in medical facilities.
There Are Lawsuits Against Philips for Harm from Their CPAPs
With more than 15 million recalled devices, many people are filing lawsuits seeking compensation from Philips for the harm caused by these dangerous medical devices. If you have questions about whether you or a loved one suffered harm from a Philips CPAP or similar device, speak with a lawyer as soon as possible.
How You Can Afford Your Philips CPAP Lawsuit Lawyer Serving Florida
A Philips CPAP lawsuit is a personal injury case called a defective medical device injury claim. As with other personal injury cases, we do not charge any upfront legal fees to our clients to handle Philips CPAP lawsuits. We do not get paid by the hour on these claims.
Our team works on these cases on a contingency-fee basis. This fee arrangement means that we get paid a percentage of the insurance proceeds or jury award at the end of the matter.
Also, our CPAP lawsuit lawyers get reimbursed at that time for case costs they paid on your behalf during the claim or lawsuit. You do not even have to pay the court filing fee to start the Florida Philips defect case. Our firm takes care of those expenses and gets reimbursed at the end.
Chalik & Chalik Injury Lawyers Can Provide Philips CPAP Lawsuit Legal Help
We help people who get injured because of the carelessness of others. If you want honest, relatable representation, you have found the right place. Our clients get to work directly with one of the law firm partners, Jason and Debi Chalik.
Our team is happy to offer a free initial consultation. You can call Chalik & Chalik Injury Lawyers today at (855) 529-0269 to get started. We have secured millions for our past clients. Let us help you, too.
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