TAMPA, Fla. — Millions of Americans with sleep apnea are facing what they call a nightmare. One of the biggest manufacturers of CPAP, BIPAP and ventilators recently recalled nearly 4 million products, and we’re now finding out it could take a year for the devices to be fixed or replaced putting people in Tampa Bay and around the world into a potentially life-threatening situation.
Five years ago, Michael Combs discovered something frightening.
“I snore and I snore hard but then when the snoring stops, I would stop breathing,” he explained.
A doctor diagnosed him with severe sleep apnea and prescribed a CPAP machine.
“The biggest issue is I stop breathing and no one is there to see me do it,” he added.
Now, the device he relies on called a DreamStation is part of a nationwide recall.
“It’s a healthcare device that some of us desperately need to stay alive," Combs said.
Back in June, Philips recalled Combs' device and millions like it after the healthcare company discovered the noise-reducing foam inside the machines could break down and cause health issues including cancer.
That put Combs and others into an impossible situation: Either keep using a device that could make them sick or be at risk of stopping breathing while sleeping.
Employees at Suncoast Medical Supply are fielding questions from customers every day.
“Everybody is scrambling how to get new CPAPs, how to get theirs fixed, buying other brands and they’re just out of them everywhere,” said CEO Barry Baldwin, adding that the recall is now causing other brands to sell out, leaving them with few options to give customers.
Combs tried to get an appointment with a pulmonologist to get his CPAP machine inspected and found out they’re booked until late November.
“The biggest problem is we’re stuck,” he elaborated.
For now, Combs is making the decision to keep using his recalled CPAP, but he worries about what it could mean long term for his health.
“When can I get some help? when will I get answers?” Combs questioned.
If you have one of the recalled devices, you’re urged to register it as soon as possible on Philips’ website.
Philips also provided a statement to ABC Action News stating: "We fully understand and regret the impact that this is having on patients. We have launched a comprehensive patient and customer communication program, which includes dedicated mailings, call centers and websites in more than 100 countries. This is a complex undertaking and patients may have learned about the recall notification via the news, before they received the direct mailing/letters. In the US, Philips does not own or manage the CPAP patient’s contact information – many patients purchase their devices through third parties. Therefore this broad approach was the fastest way to inform patients of this issue. Philips is working with those third parties (Durable Medical Equipment providers - DMEs) to also reach patients directly as quickly as possible. We are working around the clock to continue to reach out to our customers and patients. The structural solution of the component quality issue is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam. Philips recently announced the start of the repair and replacement in the US. The replacement of certain affected devices is already underway."
A Philips spokesperson added if a Durable Medical Equipment provider (DME) registers a product for a patient, the DME will manage the replacement process and be in contact regarding the status and expected time frame. If a patient registers their product, Philips and the DME will consult to determine which organization will manage the replacement process. If the DME authorizes Philips to perform the replacement, Philips will be in contact regarding the status and expected time frame. "This process is necessary to move forward, and may take some time," a spokesperson wrote in an email.