PENNSYLVANIA, USA — It's been almost a year since millions of Philips CPAP machines were recalled. People who use the machines to sleep at night say it's been a nightmare to navigate and say they're still not getting a lot of answers.
FOX43 Finds Out why it's taking so long to fix the problem and how many people may have died because of it.
Christopher Taylor used a Philips CPAP machine every night for about 7 years.
"I have this overwhelming fear of 'is today the day I'm going to find out that machine killed me?'" he said recently.
Taylor stopped using the machine last June, when his device and millions of others were recalled.
At the time, Philips said the noise-canceling foam inside the machines can break down. Those particles and gases from the foam can cause issues if they're inhaled.
Taylor said, "I had to go six months, maybe seven, without CPAP machine, waking up not breathing all the time, just scared to sleep you know."
He has a new machine now but is still fearful that using his old machine for years caused damage that he may not be able to see.
Since April of 2021, the FDA received more than 124 reports of deaths suspected to be related to the foam breakdown in the devices.
While the FDA investigates, people like Taylor have decided to take legal action against the company. He joined a class-action lawsuit.
"I'm going to take this all the way to the courts because my voice needs to be heard," he said.
There are reports of hundreds of lawsuits against the company and claims that Philips knew about the issue long before the recall.
Philips says "we're working as fast as we can."
FOX43 Finds Out Reached out to Philips about the recall and how customers are not satisfied.
We were sent the following statement:
"Please let me start by saying that we regret the concern and inconvenience that the June 2021 recall notification for specific CPAP, BiPAP and mechanical ventilator devices may have caused for patients and care providers, and we apologize for that. This is one of the largest field actions in the medical technology industry, and we take the remediation very seriously.
We have established a dedicated team of 1,000 colleagues working under direct supervision of Philips' Executive Committee. We have taken a systematic approach to addressing the unknowns and expand production capacity. In an average year, Philips Respironics produces and distributes around one million sleep devices. In the meantime, we have scaled up production by a factor of 3, but inevitably it still takes time to remediate over 5 million devices. While we are working as fast as we can, we acknowledge that this is taking an inevitable amount of time, which has been worrying for patients.
More information on the recall notification, as well as instructions for customers, users, and physicians can be found at www.philips.com/src-update. Patients with affected devices currently in use are requested to register their products on this website to facilitate the repair and replacement program.
With regard to the latest FDA report that you reference, please see our most recent statement here."
Taylor says he has yet to be contacted by Phillips.
"We trusted in that company to give us a product from dying in our sleep that could kill us in 30 different ways or more," he said.
The FDA has been in contact with Philips since the recall, and right now it seems like the priority here is for Phillips to Issue an Order for Device Repair, Replacement, or Refund.