More problems Philips Respironics: sleep apnea devices also remain a concern – published at cemarking.net – May 5, 2022
It continues to ail with Philips Respironics’ devices. After yesterday’s publication on the recall of the V60 family of ventilators, we now continue with the problems surrounding Philips Respironics’ sleep apnea and respiratory devices. Elise Reuter of MedTech Dive recently published an article on the latest problems at the manufacturer. In this article she talks, among other things, about the subpoena issued to Philips Respironics by the U.S. Department of Justice.
Subpoena for Philips Respironics
On April 8, 2022, the company received a subpoena from the U.S. Department of Justice. In it, it is summoned to provide information about the recall of their sleep apnea and respirators. Last week, the Royal Philips CEO, Mr. Frans van Houten, indicated that the company will spend even more money to solve the quality problems at Respironics. In a response to the subpoena, he said:
“At the moment it is a subpoena for information. This means that the prosecution is preparing an investigation. We just have to accept that.”
Frans van Houten (Royal Philips CEO)
“Requiring Philips to Present a Recall Plan “
The Center for Devices and Radiological Health (CDRH) is proposing to require Philips to submit a plan for recalling sleep apnea and respirators. The CDRH is the division of the United States Food and Drug Administration (FDA) responsible for approving all medical devices before they are marketed. It also oversees the production, performance and safety of these devices.
What is Going on With These Devices?
Back in 2021, Philips announced that there were problems with the soundproofing foam of the Dreamstation series of sleep apnea and breathing devices. As a result, there is a risk of users inhaling or swallowing particles. This in turn leads to those users potentially being exposed to harmful substances. An FDA spokesperson stated at the time, “Once broken down, the foam can cause serious injury, including injury that may be life-threatening, cause permanent injury, and/or require medical intervention to prevent permanent injury. “
From that point on, Philips Respironics’ quality problems accelerated. As a result, the scope and cost of the original repair and replacement program increased significantly. However, in some cases patients may continue using the affected devices if stopping would pose a greater risk than continuing to use it. You can read this in the FDA’s Safety Communications about the recall. The latest update in this publication is from May 2, 2022.
What does the near future look like?
It is likely that the effects of the quality problem will last for a long time. Even after Philips has repaired or replaced the affected devices. Additionally, in March 2022, there were no less than 185 personal injury lawsuits pending against Philips. Furtermore, there were also 100 class actions related to these problems. Philips expects the class actions to be consolidated into two cases in the summer. In conclusion we can say that the end of the misery at Philips Respironics does not seem to be in sight for the time being.
More Problems Philips Respironics: Sleep Apnea Devices also Remain a Concern: Sources, Links and Downloads
- Elise Reuter of MedTech Dive
- Jim Hammerand of MedicalDesign
- FDA Safety Communications about the recall
Other related articles that may be of your interest:
- Philips Respironics Voluntarily Recall of V60 Ventilator Product Family
- Philips Health Systems Ventilators Safety Hazard Alert
In addition, some more blogs about this subject: