The Dutch medical equipment company, Philips, recently issued a voluntary recall of certain sleep apnea devices and ventilators. The recall is due to health risks associated with the sound abatement foam. The foam component is meant to reduce the sound of the device. However, the recall cites the danger for the foam to degrade into particles. These foam particles may then enter the device’s air pathway and users could ingest or inhale them.

The recall targets between three to four million devices. It’s also in its infancy so the extent of any health risks is not yet known. However, the pandemic also sparked a massive influx of ventilator production. As such, the defects in Philips products have the potential to cause widespread damage. This also means potential for substantial litigation in the months and years to come.

The Devices in Question

Several Philips devices are named in the recall. This includes the Philips Bi-Level Positive Airway Pressure (Bi-Level PAP) and Continuous Positive Airway Pressure (CPAP). In addition, the company recalled certain mechanical ventilator devices that use the polyester-based polyurethane (PE-PUR) sound abatement foam component. The majority of the affected devices are part of the company’s first-generation DreamStation product family. Philips has produced millions of these devices and in 2020, received a complaint rate of 0.03%. About 80% of the affected devices are CPAP machines used by those suffering from sleep apnea. Further, and about 20% are ventilators. The Bi-Level PAP machines make up the remainder of the recalls. About two-thirds of Philips CPAP machine sales are in the United States. The specific models subject to the recall are:

  • All Philips CPAP devices manufactured before April 26, 2021
  • All Philips BiLevel PAP devices manufactured before April 26, 2021
  • E30 model continuous ventilator, minimum ventilatory support for facility use
  • DreamStation non-life supporting continuous ventilator models ASV, ST, and AVAPS
  • SystemOne ASV4 model continuous ventilators, non-life supporting
  • C Series continuous ventilator, non-life supporting models ASV, S/T, and AVAPS
  • OmniLab Advanced Plus in-lab titration device
  • SystemOne Q series models of non-continuous ventilators
  • DreamStation CPAP, Auto CPAP, and BiPAP ventilator models
  • DreamStation Go CPAP and APAP models of non-continuous ventilators
  • Dorma 400 and 500 CPAP models of non-continuous ventilators
  • REMStar SE Auto CPAP models of non-continuous ventilators
  • The Trilogy 100, Trilogy 200, Garbin Plus, Aeris, and LifeVent continuous ventilators
  • The A-Series BiPAP V30 Auto and Hybrid A30 continuous ventilators for minimum ventilatory support for facility use
  • A-Series BiPAP A30 and A40 non-life supporting continuous ventilators, which are sold outside the United States

The Potential Injuries

Aside from the foam entering the user’s airway, it may also off-gas certain chemicals into the air. The foam’s degradation may also be exacerbated by high heat and high humidity. This may also be impacted by unapproved methods of cleaning the device. Foam ingestion, inhalation, and chemical off-gassing can cause headaches, irritation, inflammation, and respiratory issues. Such exposure is also toxic and carcinogenic. According to Philips, the company has not received any reports regarding the effects of chemical emissions. No deaths have been reported from the use of these devices.

The recall advises patients using the CPAP and Bi-Level PAP devices to discontinue use. But for those that do not have an alternative, Philips advises them to consult with their physician to determine if the benefits outweigh the potential risks. For patients using ventilators, the recall warns users to speak with their physicians before ceasing use. The company also recognizes that alternate treatment may not be an option for patients using ventilators for life-sustaining therapy. “In these situations,” the company advises, “and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identifies in the recall notification.”

Philips publicly stated that it aims to address all affected devices as expeditiously as possible. Philips plans to modify the sound abatement foam on its DreamStation products, upon receiving the requisite regulatory clearance. Further, the company’s next-generation CPAP product family, DreamStation 2, is not affected. As such, it plans to increase production of these devices while repairing and replacing those that are defective. The instructions for use have also been updated.

Future Litigation

Without much information, thus far, on the extent of patient injuries, the actual impact of these product defects is still unclear. But with any defective medical device that may cause cancer and respiratory issues, the likelihood of litigation is high. Although no lawsuits have yet to be filed, a number of law firms and consumer watch groups have put out alerts to those who may have been affected and entitled to compensation. With nearly four million devices at issue, it is only a matter of time before a lawsuit is filed.

Interestingly, this recall comes as Philips has recently shifted its focus entirely to medical devices and other healthcare products. The company sold off its domestic appliances business earlier this year. This occurred after it experienced a huge spike in production during the peak of the COVID-19 pandemic. Deeming itself “a pioneer in the field of respiratory innovation,” Philips has sold a number of its products to hospitals and healthcare providers combatting COVID-19. This includes ventilators, oxygen therapy, PAP therapy, nebulizers, airway clearance, and patient monitoring software. In fact, in April 2020, at the height of the pandemic, Philips had introduced its Respironics E30 ventilator (it is unclear whether the E30 model on the recall list is the same product) as a “ventilation alternative” in situations where full-featured ventilators are not available. Philips ramped up its production to 15,000 units per week that month. As a result, Philips products remained at the forefront of respiratory care throughout the pandemic. Suffice to say, the proliferation of Philips’ devices for the treatment of respiratory issues was nearly unavoidable in light of the pandemic’s massive ventilator shortage.

Overall, with nearly four million devices in question, the scope of Philips’ recall has the potential to be enormous.

 

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