There’s been a lot of activity around Philips Respironics CPAP machines and related devices such as BiPAP machines and ventilators in 2021. First, the company voluntarily recalled many models, citing concerns about the breakdown of a polyester-based foam used to minimize sound and vibration.
The FDA issued guidance for people using the potentially dangerous machines. Lawsuits against the company piled up quickly enough that those cases were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Western District of Pennsylvania just a few months after the recall. In September, the company announced the commencement of a repair and replacement program for the recalled devices.
But, inspection reports issued by the federal Food & Drug Administration (FDA) in November suggest that Philips had reason to know there might be serious issues with the machines long before 2021. In fact, the report repeatedly concludes that risk assessments and field corrections did not occur within an appropriate time frame.
Delayed Response to CPAP and Other Device Issues
The FDA report documented a number of instances in which Philips was notified of possible problems or even conducting testing in connection with possible problems, but failed to respond adequately to that information. Some examples include:
- In 2018, in response to reports relating to Trilogy ventilator devices, the company conducted a risk assessment. However, the assessment did not include other devices, such as CPAP and BiPAP machines, though Philips produced several devices using similar air pathways and the same foam that had triggered concerns.
- The risk assessment associated with the Trilogy concerns notes “a total of 17 cases were reported pertaining to the degraded foam in the Trilogy ventilator device.” However, the FDA’s independent search of the company’s consumer complaint database revealed that between 2008 and 2017, Philips had received more than 20,000 Trilogy-related complaints with related keywords.
- During that same period, more than 200,000 complaints were received which included one or more of the following terms: contaminants, particles, foam, debris, airway, particulate, airpath and black.
- Philips closed its health hazard evaluation on this issue with a probability of harm determination of “unlikely,” meaning that it is not likely that use of the device will cause harm, and that harm is possible but improbable. However, the FDA says the criteria for that classification were not met.
- Even this inadequate 2018 response to the Trilogy device issues came late: the report indicates that in 2015, Philips Respironics had knowledge of another Philips entity implementing a preventative maintenance servicing procedure for the Trilogy ventilators, but failed to investigate or evaluate the risks. In 2016, testing did reveal concerns about the damping foam in the Trilogy device, but no corrective action was taken.
- In 2019/2020, a DreamStation 1 device failed emissions testing for volatile organic compounds and Aldehydes.
- In late 2020, a biological risk assessment report stated “The cytotoxicity and positive genotoxicity results observed from degraded PE-PUR foam samples indicates a potential patient risk.” The same report concluded that, “…the degraded PE-PUR foam…presents a significant biological risk to those patient populations who are exposed to downgraded PE-PUR foam.”
With all of this information and more available, Philips didn’t recall the affected devices until June of 2021, two months after divulging the concerns to shareholders. And, the delay isn’t the only concern raised by the FDA report.
Other Concerns in the FDA’s Philips Respironics Report
The FDA’s first reported observation is perhaps of greatest concern to users of CPAP and BiPAP devices, ventilators, and similar products. The agency said there was no documented support for the company’s determination that only the recalled devices posed a risk. In other words, it’s uncertain whether similar devices that have not been included in the recall may pose the same threats.
The FDA also raised concerns about the material used in the repair and replacement program currently underway, and instructed the company to arrange for independent testing.
If you or a loved one has been harmed by a faulty Philips Respironics CPAP machine or similar device, it’s time to take action. Just fill out the contact form on this site, and we’ll put you in touch with a CPAP litigation attorney serving your area.
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