Millions of people who suffer from respiratory disorders rely on medical devices to help them breathe. But some patients tell 7 Investigates they’re panicking — because their machines were recalled and could be dangerous. Now they say they’re stuck in a lose-lose situation. Hank Phillippi Ryan has the story.
John says his life is so much better because of his CPAP machine.
It provides a steady stream of air into this nose mask. John needs the device to sleep.
He has a condition called “obstructive sleep apnea” which makes his airway narrow – cutting off his oxygen.
The device keeps him breathing well. Before he had it, “You wake up miserable, groggy, depressed, angry,” John says.
Beyond being exhausted, medical experts say sleep apnea patients could be more likely to suffer a heart attack or a stroke. “This is my lifeline,” John says.
CPAP’s can be noisy, so there’s special foam inside to keep them quieter.
And turns out– that’s a problem.
John recently learned the machine he depends on was recalled.
The official recall notice says the sound abatement foam may degrade into particles and be ingested or inhaled which can result in serious injury which can be life-threatening and cause possible toxic and carcinogenic effects.
The recall involves millions of respiratory devices made by Philips Respironics, a subsidiary of Philips.
“It was surprising,” John says.
The company says it’s working on a “repair and replacement program.”
But John just got an email from Philips saying it will take about 12 months for his repair or replacement.
That leaves him and millions of others with a difficult decision. “Do you take the chance on using the machine? Or do you stop and live life like you used to, in a zombie state of not having great sleep?” John says.
The company says people with recalled CPAP machines should stop using the devices and consult with their physician.
John’s doctor is telling him to buy a new device that’s not part of the recall. But that could cost more than a thousand dollars and may not be covered by insurance.
Lawyers have filed more than a dozen lawsuits in federal court in Boston against Philips. The company’s North American headquarters is in Cambridge.
One suit wants the company to pay for ongoing medical monitoring and give patients a refund, or replacement with a non-defective device.
“We want them to be reimbursed for the trouble, the headache they’ve gone through, the anxiety that this is causing,” Makenna says.
For now, John is struggling. He can’t find a new machine in stock. And the one he’s using could be harming him.
“It’s a rock and a hard place,” John says.
Philips tells us they do not comment on pending litigation but that they are mobilizing their resources to fix this problem. They say they are committed to getting a repaired or replacement device to people as soon as possible.
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