Sleep Apnea Patients Left Frustrated and Waiting as Massive Philips CPAP Recall Drags on

FORT WORTH (CBSNewsTexas.com) – The mass recall of millions of sleep apnea machines, dragging on for nearly two years, has left many patients waiting with seemingly no good options.

In June 2021, Philips Respironics recalled over 5 million SCBAs.

The company warned that the foam, which is meant to reduce noise, breaks off and enters users’ mouths. Inhaling foam particles, the company wrote in a 2021 notice, could result in “serious injury that could be life-threatening.”

Philips Respironics, which manufactures more than 40% of sleep apnea devices, initially expected to be able to replace all failed devices within a year. However, after more than a year and a half, many patients are still waiting.

“It was terrible,” said White Settlement’s Janet Gray, whose Philips Respironics DreamStation CPAP was one of the recalled models.

“You are afraid to go to bed because if you go to bed without it, you may die. But if you go to bed with him, it could kill you in the future,” she said.

Philips Respironics said it has now completed 90% of the devices required for the initial recall.

Gray received a refurbished replacement almost 18 months after the recall. The foam inside was pulled out and replaced with silicone.

However, Gray said she would not use it.

“I don’t trust it,” she said. “I trust him less than the first.”

Since April 2021, the US Food and Drug Administration (FDA) has received 98,000 complaints related to foam breakdown in Philips Respironics breathing devices. Complaints included infections, chest pain and cancer. There were also 346 death reports. The FDA said these reports help identify problems, but because they are self-reported, they lack validation.

Philips Respironics said it did not find “convincing data linking these devices and reported deaths.” A company spokesperson told I-Team that following the 2021 recall, the company ordered additional testing and found no link between its devices and cancer.

The FDA called the new Philips Respironics analysis “inconclusive.”

Dr. Vikas Jain of Dream Sleep Medicine in Frisco said the lack of information from Philips Respironics about the recall left doctors in a difficult position. The certified sleep specialist said he still has new patients who don’t know their devices have been recalled. Jain said that due to the lack of a clear schedule for when patients would receive replacements, it was extremely difficult to give reasonable advice to patients.

“For the company to come to us and say, ‘We don’t know when we can send a replacement, but you have to talk to the patient and decide if they should continue using the device.’ “It’s a difficult place,” said the Frisco doctor. “I have to decide whether the patient should use a device that can cause cancer or not use it at all. It will be a burden that you put on doctors without having a clear process.”

While doctors don’t know what to tell patients, shortly after the recall, the FDA conducted an inspection of Philips Respironics’ manufacturing facility in Pennsylvania.

In the report, federal inspectors noted that Philips Respironics was aware of the foam problem in its breathing devices as early as 2015, six years before the recall. However, according to the FDA inspection report, no additional design changes or corrective actions were taken.

A Philips Respironics spokesperson told the I-Team: “In previous years, there have been few complaints about foam breakdown. [Philips Respironics] evaluated and reviewed on an individual basis. Potential concerns related to emissions of volatile organic compounds have become apparent only recently. When Philips became aware of this issue and its potential significance in early 2021, action was taken which resulted in the issuance of a safety notice in June 2021.”

Late last year, Philips Respironics began recalling about 20,000 refurbished devices, citing two different issues: some remanufactured devices still showed foam residue, and the silicone that replaced the foam peeled off in some cases and could potentially block airflow. flow. Last month, the Food and Drug Administration marked this as a first class recall, meaning it’s the most serious type. (Gray’s replacement device was not on the recall list.)

Philips has recalled the following devices manufactured between 2009 and April 26, 2021:

• BiPAP A30 Series A
• BiPAP A40 series A (ventilator)
• Hybrid BiPAP Series A A30
• BiPAP V30 Auto (ventilator) A series
• C-Series ASV (fan)
• C-series S/T and AVAPS
• dream station
• DreamStation ASV
• DreamStation Go
• DreamStation ST, AWAPS
• Dorma 400
• Dorma 500
• E30
• Garbin Plus, Aeris, LifeVent (fan)
• OmniLab Advanced+
• REMstar SE Auto
• SystemOne ASV4
• SystemOne (Q series)
• Trilogy 100 (fan)
• Trilogy 200 (fan)

Philips has also recalled certain Trilogy Evo ventilators manufactured between April 15, 2021 and May 24, 2021 with specific serial numbers.

If you are using a recall device, the FDA recommends the following:

• Do not stop or change the use of the ventilator until you have spoken to your healthcare provider.
• Talk to your healthcare provider about using the built-in bacteria filter, which can help filter out pieces of polyurethane foam, as outlined in the Philips recall notice. At this time, information provided by Philips does not indicate that filters can reduce the risks associated with PE-PUR foam. The FDA’s evaluation of the information provided by Philips is ongoing. It is important to pay attention to the following considerations: 1) Built-in bacterial filters will not help reduce contact with some of the chemicals that can be released from the polyurethane foam. 2) Built-in bacterial filters may increase the resistance to airflow through the device, which may result in insufficient ventilation of the fan. 3) If your ventilator has a built-in bacterial filter, be careful not to let pieces of PE-PUR foam accumulate on the filter or cause airflow problems.
• Register your device on the Philips recall website or call 1-877-907-7508 to provide important additional information to help you prioritize replacement of your device and receive updated information from Philips. For Spanish translation, press 2; Pair Spanish, oprima 2.
• If you have any health concerns, including those listed in the Potential Health Risks section, or any problems with your device, talk to your healthcare provider and report the problem or concern through the MedWatch Voluntary Report Form.