investigations

CPAP Machine Recall Leaves Sleep Apnea Patients Wanting Answers

Millions of Americans who suffer from sleep apnea need to check their Philips CPAP and breathing machines for a potentially dangerous defect.

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“My heart just fell from my chest,” Frank Reese said.

It’s been three months since Frank Reese from Bridgeport first learned that his Philips CPAP machine had been recalled.

“Actually, it was kind of a fluke,” Reese said.

He tried to order supplies for his machine from his medical services provider back in June and that’s how he learned the DreamStation machine he’d used for years was being recalled due to a potentially dangerous defect.

“I still have that fear of what if I come down with cancer? If I have breathed something that's toxic into my body from this machine?” Reece said.

In June, Philips recalled millions of its CPAP, BPAP and ventilator machines due to potential health risks from its sound abatement foam. Testing results show that polyurethane material can degrade into tiny particles and be inhaled or swallowed.

The FDA says the health risks could be life-threatening and can cause permanent impairment including toxic or carcinogenic effects to organs, asthma and irritation to the respiratory tract.

Frank registered his device with Philips in early August and while the company says it’s launched a comprehensive communication program to notify patients, including call centers and dedicated mailings, Frank says he’s heard nothing from Philips.

“They're proposing some potential toxic or cancer forming developments down the road, but we just don't know it's too soon to understand that,” Dr. Jeff Nascimento said.

Nascimento, a pulmonologist with Hartford Healthcare Medical Group, recommends patients with more moderate to severe sleep apnea to continue using the CPAP machine until they can get a new device and for those with a milder case of the disease to stop using the machine for now.

“At this point, we're just waiting to hopefully, get more influx of these devices so that patients can get replacements and they don't have to worry about the potential harm to them,” Nascimento said.

“We’re continuing to put a tremendous amount of pressure on them,” Connecticut Attorney General William Tong said.

Tong says 11 complaints have been filed in his office along with other calls and emails from concerned Connecticut patients. He says his office has gotten some response from Philips but he’d like to hear more from the company.

“People literally depend on them for life and the fact they could be breathing carcinogens and these devices are faulty is unacceptable and Philips needs to make it right,” Tong said.

While Frank’s insurance plan did not cover the cost of a new CPAP machine, his doctor was able to supply him with an alternative brand until Philips’ replacement comes through.

Earlier this month Philips said, “it anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices and intends to complete the repair and replacement programs within approximately 12 months.”

Reece says that’s too long for patients like him and especially ones who don’t have an alternative.

“I think they need to expedite the replacement of the machine. It needs to be ASAP,” Reece said.

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