MILWAUKEE — In June, health-tech company Philips announced a recall for millions of its respiratory machines including sleep apnea devices and ventilators.
It's almost September and Lindsay Zeman of Milwaukee tells the I-Team she is still waiting for a new device or a repair.
"I tried sleeping without it. I literally can't sleep without it or I'll just be gasping for air the entire night," said Zeman, who owns a Dreamstation sleep apnea machine included in the recall.
Every night before Zeman goes to bed, she has a hard decision to make. Either use her recalled sleep apnea machine or don't use it and risk not being able to breathe.
"I have open heart surgery in less than a month, and I don't want my recovery to be slowed down or something else to happen to my heart while I'm wearing this machine that I shouldn't be using."
Philips reports three to four million of its breathing products have been recalled globally citing health risks from the foam inside.
"There's a foam for sound abatement inside the machines that can disintegrate and be inhaled by people while they're using the machine at night. So that's one issue. The other issue, is that the foam as it deteriorates and disintegrates emits this toxic gas," said Makenna Cox, an attorney with Girard Sharp. Her firm is handling one of the dozens of class action suits across the country filed against Philips.
"Has your firm been in touch with any consumers who have actually gotten sick from these devices?" the I-Team's Kristin Byrne asked Cox.
“At this point, it’s so early and we know very little from Philips, but we’ve spoken with many people with serious injuries of the nature described in the recall, including lung cancer, pulmonary fibrosis, and COPD, and other serious respiratory illnesses," said Cox.
The I-Team reached out to Philips asking several questions ( 1.) This massive recall happened in June. Why are consumers still waiting for answers from Philips? 2.) Has Philips replaced or repaired any of the machines yet? If so, how many? 3.) How much longer do consumers impacted have to wait? 4.) Has Philips been notified of any consumers who have become ill or injured from any of the recalled devices?)
Philips responded via email with the below statement:
On June 14, 2021, Philips voluntarily issued a global field safety notice for specific affected devices within its Sleep & Respiratory Care portfolio. The company also issued a global press release on the notice on the same date.
Philips provides update on recall notification - News | Philips [philips.com]
In relation to your question on the recall notification process, in accordance with medical device regulations and laws in the markets that we serve, Philips is required to broadly communicate a notice of this kind at the earliest possible date. This is intended to ensure wide and timely awareness of potential safety issues as well as important instructions related to clinical use of affected devices.
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.
Philips often does not own or manage the patient's contact information – many patients purchase their devices through third parties. So 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.
In relation to your query on how Philips is addressing affected devices, we have mobilized the necessary resources across the company to correct the foam component quality issue that we have identified. We fully understand the impact that this is having on patients, as their well-being is at the heart of everything we do at Philips.
Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam. The repair and replacement program will be at no cost to consumers in the U.S. Philips has taken a EUR 500 million provision to pay for this repair and replacement program.
Regarding estimated timing of the field actions, we are working to address this issue as expeditiously as possible. However, 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. The company is therefore in consultation with regulatory authorities worldwide regarding the correction program. Philips also continues to monitor and analyze reports of complaints with affected devices, in accordance with our Quality Management System and post-market surveillance activities.
At this time, Philips is already producing repair kits and replacement devices in large quantities. We have increased the production capacity of repair kits and replacement devices in the third quarter of 2021 to 55,000/week and we aim to further increase that capacity to 80,000 units/week in the fourth quarter of 2021. As our production capacity is fully focused on the repair and replacement actions, we are currently not taking orders for sleep therapy devices for new patients.
We are requesting that patients with affected devices currently in use to register their products on our dedicated web site to facilitate repair. Registration is what formally starts the repair / replacement process.
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.
Philips continues to recommend that affected patients please follow the advice of their physicians, as they are most familiar with a patient's medical history. To aid the clinician in the consultation with the patient, Philips has made the following clinical information available: Information for Physicians and other medical care providers
We will continue to publish updates at the following dedicated web site for the recall.
Senior Press Officer
Philips Global Press Office
Zeman feels backed into a corner. She's on social security and says she can't afford to buy a new machine. The devices can be around a thousand dollars and Medicaid told her it wouldn't cover the cost.
So, every night, she's back deciding between the lesser of two evils.
"I feel stuck trying to choose which health risk is worse."