Philips Recalls Ventilators, Sleep Apnea Machines Due to Health Risks
Overview of Recall
The recall includes millions of units of the Philips Bi-level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. Most of these recalled devices are DreamStation products.
Philips stated that the defect in the products was related to the polyester-based polyurethane (PE-PUR) sound abatement foam in the devices. When cleaned incorrectly or exposed to high heat and humidity, the foam can degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the users.
Potential Foam Degradation
While no deaths linked to the PE-PUR foam have been reported and the medical device maker reports that it has a low complaint rate, 0.03% in 2020, Philips did acknowledge the potential risks of exposure to the foam particles. Philips also indicated that the foam may also off-gas certain chemicals. Headaches, irritation, inflammation, hypersensitivity, nausea/vomiting, respiratory issues and possible toxic and carcinogenic effects were all concerns that led to the recall.
The medical device maker said that it will replace the current sound-abatement foam with new, non-toxic material.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing to ensure patient safety,” said Philips CEO Frans van Houten. “We are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices.”
Advice for Patients and Customers
Philips advises those using the recalled products to take the following actions:
For patients using affected BiLevel PAP and CPAP devices:
Discontinue the use of your device and work with your physician or durable medical equipment (DME) provider to determine the most appropriate options for continued treatment. To continue the use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with the affected device outweighs the risks identified in the recall notification.
For patients using affected life-sustaining mechanical ventilator devices:
Do not stop or alter your prescribed therapy until you have talked with your physician. Philips recognizes that alternative ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.
Consult a Medical Device Liability Attorney at Peter Angelos Law
All consumers are entitled to a level of protection from brands, especially brands who market their product as ones that are safe and will improve quality of life. If you or someone you love has used a recalled Philips Bi-Level PAP or CPAP machine, you may be entitled to compensation through a class action lawsuit. Consult with an experienced Medical Device Liability attorney at Peter Angelos Law by calling 1-800-556-552.
Sources for this article were gathered from USA Today, the American Association of Sleep Medicine, and Philips.