By Lorenz Duchamps
The U.S. Food and Drug Administration (FDA) announced in an update this week that previously recalled Philips breathing devices and ventilators used to treat sleep apnea may be linked to hundreds of deaths.
In a statement issued on Jan. 31, the FDA said that since April 2021, it has received more than 116,000 medical device reports (MDRs), including 561 reports of deaths associated with foam breaking down in Philips Respironics ventilators, BiPAP sleep therapy devices, and CPAP machines that were included in a major recall announced in mid-2021.
The agency noted that between July 1, 2023, and Sept. 30, 2023, it received more than 7,000 MDRs, including 111 reports of deaths tied to these breathing devices and ventilators.
“A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain,” according to the FDA.
Since June 2021, Philips has recalled more than five million units of the pressurized breathing machines amid reports their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.
The polyester-based polyurethane (PE-PUR) foam used in the machines to reduce sound and vibration can break down and result in “black pieces of foam” or certain invisible chemicals being breathed in or swallowed up by the person using the device, the FDA said in a separate statement.
“The problems reportedly associated with the PE-PUR foam breakdown could potentially result in serious injury and may require medical intervention to prevent permanent injury,” the agency stated.
Philips Suspends US Sale of Sleep Apnea Gear
Meanwhile, Philips is facing cases brought by hundreds of patients who said their health has suffered due to the use of the devices, and also following the outcome of an investigation by the U.S. Department of Justice (DOJ) into the handling of the recall.
Responding to the investigation in a statement to People, a spokesperson for Philips wrote: “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.”
The company also asserts that “based on the testing and analysis to date, Philips Respironics concluded that use of its sleep therapy devices with PE-PUR foam is not expected to result in appreciable harm to health in patients. Further testing is ongoing.”
Just days before the FDA announced that hundreds of deaths may be linked to the breathing devices and ventilators, Philips agreed in a settlement with the health regulator and DOJ to stop selling new devices to treat sleep apnea in the United States as it works to comply with a tentative agreement that could cost the Dutch technology company nearly $400 million.
The agreement, which Philips executives disclosed during a quarterly earnings update, has not yet been finalized and will have to be approved by a U.S. judge.
Under the agreement’s terms, Philips would continue servicing previously sold machines in the United States but couldn’t sell new ones until it meets corrective actions laid out by the FDA. Company executives said they have set aside $393 million for operational changes and upgrades needed to comply.
According to the company’s update, Philips faces similar legal challenges in Canada, Australia, Israel, and Chile.
According to an FDA notice updated on Jan. 31, Philips has recalled the following devices manufactured between 2009 and April 26, 2021, as they may pose a serious health risk due to the breakdown of PE-PUR foam.
- 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 ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
The company also recalled certain Trilogy Evo ventilators distributed from April 15, 2021, to May 24, 2021. The devices have specific serial numbers that can be found here.
Most recalled devices are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep passageways open during sleep.
CPAP and BiPAP machines are worn at night to help those with sleep apnea.
According to the Cleveland Clinic, sleep apnea is “a disorder that causes you to stop breathing while asleep. Your brain tries to protect you by waking you up enough to breathe, but this prevents restful, healthy sleep.”
Reuters and The Associated Press contributed to this report.
From NTD News