En español | The Food and Drug Administration (FDA) has authorized Philips to start repairing the first-generation DreamStation sleep apnea machines that were recalled in June because foam used in the devices posed health issues to consumers.
The company announced that it will begin repairing devices this month and has already started replacing certain first-generation DreamStation CPAP devices with a newer version of the product. Phillips expects the repair and replacement programs to be complete by September 2022.
Millions of its sleep apnea machines and life-sustaining ventilators were listed under the Class I recall, the most serious type, because use of the products can result in serious injuries or death. The company announced that foam used in the breathing devices may degrade into particles and be ingested or inhaled by users. The foam may also give off chemical emissions. Exposure to foam particles or emissions is potentially toxic, the manufacturer said, and may cause cancer, among other health risks.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” Philips CEO Frans van Houten said in a statement. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients.”
He urged patients with affected devices to register them on the company’s recall website, phillips.com/src-update. Patients or caregivers can look up their device’s serial number and begin a claim if their unit is affected. Make sure not to input any spaces or the letters “S/N” when looking up a machine.
Those with affected PAP and CPAP devices should discontinue using them and work with their provider to determine the best option for continued treatment. Patients using life-sustaining mechanical ventilators should not stop using the devices before talking to a doctor about alternatives.
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Numerous complaints and injuries
Since the recall was first announced, the FDA has recorded more than 1,200 complaints and over 100 injuries related to the issue.
The recall affected an estimated 3 million to 4 million devices globally, based on the company’s production and shipment data. The devices were distributed from July 2009 to April 2021, and over half of them were sold in the U.S. The majority of the recalled products are the first-generation DreamStation machines. DreamStation 2 devices are not affected.
Philips is aware of consumers finding black debris within the air-path tube and feeling sick. Potential risks from exposure to the foam include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.
The specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices that were recalled are listed by the company here with steps for consumers to take.
The company said that it sent letters to users with instructions for registering online to have affected devices repaired or replaced. Anyone who didn’t receive a letter should call Philips at 877-907-7508.
Sleep apnea in older adults
Sleep apnea is a common condition in the U.S. that occurs when the upper airway becomes blocked during sleep, reducing or stopping airflow. The majority of those affected with sleep apnea remain undiagnosed. A mechanical device such as a CPAP machine can be used to treat sleep apnea by pumping air through a tube into a mask worn by a person with sleep apnea.
The risk for sleep apnea increases as you get older. Sleep apnea may affect between 38 percent and 68 percent of people over 60, a study from the Centers for Disease Control and Prevention (CDC) found. According to the National Institutes of Health (NIH), normal age-related changes in how the brain controls breathing during sleep partially explain the increased risk with age. Another reason may be that more fatty tissue builds up in the neck and tongue as we get older.
Other causes of sleep apnea include obesity, large tonsils, endocrine disorders, neuromuscular disorders, heart or kidney failure, genetics, and premature birth.
List of recalled Philips CPAP machines, ventilators
- E30 (Emergency Use Authorization)
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- SystemOne (Q series)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- A-Series BiPAP V30 Auto Ventilator
Editor’s note: This article, originally published June 15, 2021, has been updated to reflect the FDA’s recall classification and complaints received.
Aaron Kassraie writes about issues important to military veterans and their families for AARP. He also serves as a general assignment reporter. Kassraie previously covered U.S. foreign policy as a correspondent for the Kuwait News Agency's Washington bureau and worked in news gathering for USA Today and Al Jazeera English.