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woman in hospital using an Apparatus for artificial lung ventilation

If you have a CPAP (continuous positive airway pressure) machine that you use to treat your sleep apnea, you should check it out closely. Philips recently recalled millions of these devices along with many ventilators because of potential health risks.

Philips Warns About Possible Foam Degradation in CPAP Devices

In its 2021 first quarterly report, Philips noted that it had received user reports and testing indicating possible risks to users related to the sound abatement foam used in certain Philips’ sleep and respiratory care devices. This foam helps eliminate sound and vibration from the devices so they operate more quietly.

It seems the foam may degrade under certain circumstances, including:

  • Using unapproved cleaning methods, such as those involving ozone
  • High humidity and temperature

The majority of the affected devices are in Philips’ first-generation DreamStation product family. The company’s newer line—DreamStation2—is not affected according to the report.

Philips Recalls Millions of Devices with Sound Abatement Foam

Philips then provided an update to that warning on June 14, 2021. In that update, the company announced it was issuing a voluntary recall for specific devices including:

  • Bi-Level Positive Airway Pressure (Bi-Level CPAP)
  • CPAP machine
  • Mechanical ventilator devices

The company explained that it implemented the recall to address the potential health risks related to the sound abatement foam in these devices. To date, Philips has produced millions of these devices using polyester-based polyurethane (PE-PUR) foam. The company determined based on testing that the foam could degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user.

So far, the company is aware of no reports of death as a result of these issues. The potential risks of exposure to the foam particles include:

  • Headache
  • Irritation
  • Hypersensitivity
  • Inflammation
  • Nausea/vomiting
  • Respiratory issues
  • Possible toxic and carcinogenic effects

Consumers Should Check with Their Doctors

Based on an analysis of the potential health risks, Philips has advised consumers as follows:

  • For those with Bi-Level CPAP and CPAP devices—stop using these immediately and talk to your doctor about other options.
  • For those using life-sustaining mechanical ventilator devices—talk to your doctor before making any changes. Alternatives may be limited.

The company is working on a proper remedy, which will likely include replacing the current sound abatement foam with new material. As part of the recall, it will notify first-generation DreamStation product families when the different sound abatement foam is available.

For more information, consumers and doctors can contact their local Philips representative or check the Philips recall website.

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