KGUN 9 On Your SideNewsYou Ask. We Investigate.®


Cancer patient facing challenges to get replacement of recalled machine

Losing sleep over CPAP machine recall
Posted at 1:56 PM, Nov 14, 2021
and last updated 2021-11-15 13:24:08-05

TUCSON, ARIZ. (KGUN) — Donna Seals loves her kids and after finalizing a recent adoption and bringing three new children into her family, the mother of nine and grandmother has been looking forward to celebrating the holidays and creating new memories with her loved ones.

Now that future is at risk, that's because Donna received some bad news about her health, she discovered she has rare form of leukemia. Time is of the essence to get all of the medical help she needs to prolong her life.

"I was diagnosed in 2020 with chronic myeloid leukemia, I also have some lung issues as well as kidney and liver issues. The last bone marrow biopsy I had done is not good,” Seals said.

Seals started using a CPAP machine ten years ago after a finding out she had sleep apnea. Since then, she’s had three machines and two of them have been recalled. The latest is her Dreamstation CPAP machine made by Philips. Seals found out about the recall after doing an online search about her machine and stopped using it over the summer, she also says she never received a notice from Philips.

In June of 2021, the Food and Drug Administration (FDA) and Philips both announced a recall for the Dreamstation and other CPAP machines.

"I’ve had this particular one since 2019. It's affecting me it's affecting my cancer it’s affecting every part of my health,” Seal said.

Seal says getting a replacement has been a nightmare when she registered her machine for the recall, she found out it can take anywhere from one month to a year to get a replacement. On top of that, she's on disability and can’t afford the nearly $1,000 price tag for a different brand.

"Medicare will only replace them every five years. They won't replace this one because it's not within the parameters of the five years,” Seal said.

According to the FDA, the polyester-based sound proofing foam filters inside the machines can break down and release particles into the machine causing users to breathe it in.

The FDA also says it can potentially cause cancer and affect your liver, lungs and other parts of the body.

So far, 1200 complaints and 100 injuries have been reported to the FDA in connection to the machines.

"When you go through the pain it's just another thing the breathing problems and such that you have to fight,” Seal said.

KGUN 9 reached out to Philips about the situation and we’re told they regret the impact this is having on patients. The company is also sending out 55,000 repair kits per week. The company statement went on to read in part:

“Given the number of devices currently in use (estimated at 3 to 4 million units globally based on production and shipment data – about half are in the U.S.), we expect to complete the repair and replacement programs in each country within approximately 12 months from obtaining the relevant regulatory clearances.”

At this point, the FDA hasn’t reported any deaths resulting from the recalls.

In the meantime, Donna will take it one day at time to while she waits to get the help, she needs to live a better quality of life with her family.

"They need to communicate to me to help me understand when I’m going to be able to receive mine. I know I’m not the only one I’m just trying to get through and get some answers,” Seal said.

Click here for a link to the issued recall notification from Philips.

Click here for a link to the recall from the FDA.