Recalled Sleep Apnea Machines Linked to Injuries

People who use Philips ventilator, CPAP, or BiPAP machines should check if their device is part of a 2021 recall linked to over 100,000 serious injuries.

On January 31, the FDA issued an update regarding a 2021 recall of Philips Respironics (Philips) ventilators, bilevel positive airway pressure AKA Bilevel PAP, BiPAP, or BPAP machines, and continuous positive airway pressure (CPAP) machines.

These devices help improve breathing in people with obstructive sleep apnea or other respiratory conditions.

Philips recalled the machines in 2021 after learning that the polyester-based polyurethane (PE-PUR) foam used to reduce sound and vibration in these devices can break down. When the material starts to disintegrate, the person using the machine could inhale or swallow tiny pieces of black foam — potentially resulting in severe and possibly permanent injury.

The foam can also release chemicals like volatile organic compounds (VOCs), which the user can inhale.

PE-PUR foam disintegration is most likely to happen when the unit is exposed to hot and humid environments or when users clean the machines with methods not recommended by Philips.

According to the update, since April 2021, Philips has received over 116,000 medical device reports (MDRs) of serious injury related to the recalled ventilators, BiPAP, and CPAP machines.

Serious injuries reported to the agency include cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain.

However, a Philips Respironics spokesperson tells Healthnews that "the vast majority of the MDRs filed since April 2021 up to, and including, December 2023 are alleged malfunctions that do not involve reported serious injury or death."

Manufacturers are required to submit MDR reports to the FDA when they learn of adverse events occurring, such as injury or death, related to any of their devices.

Still, the FDA notes that MDRs are only one of several post-market surveillance data sources the agency uses to determine a medical device's risk vs. benefit ratio. Therefore, the agency will continue to review additional data and incoming MDRs, informing the public when more information surfaces.

List of recalled Philips CPAP, ventilator, and BiPAP machines

Though the recall occurred in 2021, individuals who use Philips machines should check the following list of products to ensure their unit is not part of the recall.

Recalled Philips devices include the following units manufactured between 2009 and April 26, 2021:

  • A-Series BiPAP A30
  • A-Series BiPAP A40 (ventilator)
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP V30 Auto (ventilator)
  • C-Series ASV (ventilator)
  • C-Series S/T and AVAPS
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS

  • Dorma 400
  • Dorma 500
  • E30
  • Garbin Plus, Aeris, LifeVent (ventilator)
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne (Q-Series)
  • Trilogy 100 (ventilator)
  • Trilogy 200 (ventilator)

Philips also recalled some Trilogy Evo ventilators with specific serial numbers distributed from April 15, 2021, to May 24, 2021.

The Philips Respironics spokesperson says, "Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these medical device reports. Importantly, the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death."

Moreover, 13 epidemiological studies found no association between use of PAP devices and increased risk of cancer in patients. Philips Respironics has been conducting test programming on the PE-PUR foam as well and has found that use of its sleep therapy devices with PE-PUR, there should be no harm done to patients. However, "further testing is ongoing," explains the spokesperson.

If a person discovers that they have a recalled machine, the FDA says they should contact their healthcare provider to discuss the next steps. They can also visit Philips' Voluntary Recall Information webpage or the Philips Patient Portal for more information.

In addition, if a person experiences an adverse health event related to these products, they can report it to the FDA's MedWatch Program.

Update
Since the publication of this article, Philips has decided to stop selling CPAP or BiPAP sleep therapy devices.


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