The United States Food and Drug Administration (FDA) warned consumers of potential safety issues and health hazards related to use of Philips Respironics ventilators, BiPAP machine, and CPAP machines in May of 2022. The government agency explained that many of the machines were under recall due to the potential for a material within the machines, known as polyester-based polyurethane, to breakdown. This material would then be basically floating around in the machine in small, sometimes microscopic, pieces. Users of the machines were at risk of inhaling these materials.
What was the danger with inhaling a small piece of material?
The FDA explained that exposure could be dangerous to the user’s health and outlined the following potential risks associated with continued use:
- Irritation of the airway
- Cancer to certain organs, such as kidney and liver
In some situations, patients chose to continue use of the defective product.
How do we know continued use of the CPAP and other machines led to injury or death?
The government requires manufacturers like Philips to file paperwork when there is evidence that a device led to the death or serious injury of a user. The FDA has received over 21,000 such reports, known as medical device reports (MDRs), related to this issue from April 2021 through April 2022.
These include reports of 124 deaths likely linked to patient use of these recalled machines.
Why did patients keep using the machines after the recall?
Philips recalled certain devices in June of 2021 but was unable to provide replacements in a timely manner. Philips put those who depend on these devices in a difficult situation: wait for a replacement or keep using the device.
What options are available for those who were exposed to this material?
Patients who used these devices may be eligible for compensation through a civil lawsuit. If successful this lawsuit would hold the device manufacturer accountable for their error and result in funds for the patient and their loved ones to cover the bills that came with needed medical care resulting from exposure to the material where exposure led to injury — like the development of cancer.