KNOXVILLE, Tenn. (WATE) — A Knoxville woman who suffers from sleep apnea is asking what does she do now after her CPAP machine has been recalled. Two months ago, the FDA recalled a group of continuous positive airway pressure devices and recommended that people stop using them.
Some of the CPAP machines that are used to help you breathe can cost up to $3,000. The device that Karen Sparkes uses was paid by for Medicare. She’s been told not to use the machine but has also been told she is not eligible for another one unless she pays for it out of her own pocket. She’s also on a fixed income.
Before she goes to bed at night, Sparkes puts on her CPAP device to help her breathe. It was medically prescribed by her doctor. The retired federal employee has a bad case of sleep apnea and if left untreated, it can lead to serious health consequences. Through Medicare, two years ago she received this Dream Station CPAP, manufactured by Philips Respironics.
In early July, she learned that the FDA recalled her device and others like it due to potential health risks. The recommendation from the FDA was to, “stop using the device.” The FDA says the recall is due to a toxic foam used in the breathing device. Once she learned of the problem, Karen called her doctor.
“He said it’s a defective machine,” Sparkes said. “You need to have a machine where you are breathing right and it’s working right. And he said, ‘we’ll get this filter, we’ll test for that.'”
But according to Karen, that filter doesn’t help. She says it makes the machine heat up.
Sleep apnea is a potentially serious sleep disorder in which breathing repeatedly stops and starts. In early July, she called Medicare asking about the device.
“She said you are eligible for a new machine because it is defective,” Sparkes said.
Sparkes’ doctor then ordered a new machine from a different manufacturer; however, she said the supplier told her she is not eligible for the device by another producer.
“I’ve only had the machine for two years, since June of 2019,” Sparkes said. “Then there is a rule in Medicare that says you have to have a machine for five years in order to get it replaced. But this is a defective machine. That means I’d have to wait another three years or pay 3,000 dollars to get a new machine.”
On Karen’s behalf, WATE 6 On Your Side contacted Medicare. A spokesperson said CMS is aware of the recall and Medicare encourages its beneficiaries to contact their supplier. Medicare says if a device is less than five years old, like Karen’s, the supplier is required by federal regulations to accept, return and replace it at no charge to the beneficiary. Karen has registered her defective machine with the manufacturer. She now intends to contact her supplier with this new information.
“I want the right machine that will work, that it is not defective. So, I can keep on trying to get better,” Karen said.
The Medicare spokesperson also said that as a result of the number of patients and devices affected by the recall, there may be a delay in getting a new device. Her next step will be getting a formal letter from her doctor and letter from Medicare saying she’s eligible for a replacement machine. She will then have to mail them to her supplier.