The company further informs that it has produced around 750,000 replacement devices and repair kits. More than 250,000 are actually in consumers’ hands.
The delay in receiving new devices has been a point of frustration for users.
Broken—or Very Much Delayed--Promises
Philips indicated it would fix dangerous, first-generation DreamStation machines by substituting new material for the defective sound abatement foam in the original devices. In June of 2021, the U.S. Food and Drug Administration (FDA) announced the recall of millions of Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. The government agency classified this as a Class I recall, which is the most serious type of recall reserved for products that may cause serious injuries or death.
This voluntary recall resulted from findings that the sound abatement foam, a polyester-based polyurethane material, could degrade. Particles or chemicals from the foam could enter the machine’s air pathway where users could inhale or ingest toxins and possible carcinogens.
The defective sound-abatement foam exists solely in Philips’ first-generation DreamStation machines. Interestingly, the company launched its DreamStation 2 devices only weeks before the recall.
Although Philips committed to replacing the dangerous foam, the company appeared to instead focus efforts on scaling up production of DreamStation 2 units.
Philips in the Legal Hot Seat For Defective CPAP Devices
Philips is keeping plenty busy these days. Not only is the company tackling the production and distribution of repair kits and replacement devices for its CPAP products, but it is also fighting multiple lawsuits. According to complaints in both class-action and individual lawsuits, Philips knew or should have known that the sound-abatement foam in the company’s CPAP, Bi-Level PAP, and mechanical ventilator devices presented health risks. Still, the CPAP User Manual for the first-generation DreamStation product family failed to warn consumers of these risks.
In addition, the lawsuits point out that when Philips recalled these medical devices, the company did so without a plan for how users who depended on the products would treat their conditions.
Philips CPAP Class Action Lawsuit Allegations
The class-action lawsuit’s filing attorney presented the plaintiff’s allegations in a PR Newswire press release. The complaint alleges that Philips was aware of the health risks of the sound-abatement foam “long before” it issued a voluntary recall of the devices that use the foam. For years, the complaint continues, device users have complained to Philips about the presence of black particles in their CPAP, Bi-Level PAP, and mechanical ventilator machines. Despite these warnings, the company allegedly failed to warn the public about the problem and its inherent risks.
Last but not least, the class action complaint alleges that Philips timed the recall of its first-generation DreamStation devices with the release of its DreamStation 2 product family. Plaintiffs accuse Philips of seeking to financially benefit from their defective machines by forcing users to buy the new devices, rather than have their defective devices repaired or replaced.