Nearly a dozen Action News viewers have reached out to the Troubleshooters for help, stating they can't get a replacement or answers.
"This is the DreamStation that turned into the nightmare station," said Rita Bekas of Cherry Hill, New Jersey. "My airway closes when I lay down to sleep, and I do not get enough air into my lungs. So I end up waking up every second, 40 times per hour gasping for air to catch a breath."
The DreamStation did help Bekas. But in June, the maker, Philips, recalled it and four million other CPAP, BiPAP, and ventilator models.
The devices Diane Hendrickson of West Deptford, New Jersey and her husband use were recalled, too.
"It's really frustrating and scary," she said. "If we don't use it, will either one of us not wake up in the morning?"
But using it could have irreparable consequences. Philips recalled the devices because the foam inside can degrade into particles that users could inhale, causing potential issues from irritation to cancer.
"I have not received any information on replacement, repair, remediation or any type of assistance with the situation," said Bekas.
In fact, Bekas said she learned of the recall only recently on Facebook and worries others may still be unaware of it.
So check your machine to see if it's part of the recall. If it is, register your machine with Philips to get a replacement or repair. But be aware, replacements will not come quickly.
"We were told by Philips that it will take a year to replace all the machines," said Dr. Mara Elena Vega Sanchez of Temple Health.
Meantime, the FDA said to stop using ozone-based cleaners because they speed up the degradation of the foam. And most importantly, call your doctor to weigh the risk of discontinuing your use of the device.
"Every case is different. So patients should not stop using their therapy until they talk to their physicians," said Dr. Sanchez.
Both Bekas and Hendrickson are looking for new machines.
"I'm calling all over," said Hendrickson, "and they're saying they don't have the machines."
Normally insurance companies, including Medicare, will pay for a new device only every five years. But there is good news. At least one insurer has committed to the Troubleshooters that it will cover at least half the cost of new machines.
The Center for Medicare and Medicaid Services (CMS) said, "Under federal regulations, suppliers must replace equipment at no charge... if it doesn't last for the five-year reasonable useful lifetime."
"I feel desperate, I need this machine," said Bekas.
Philips said it is notifying customers and expediting the production of repair kits as well as replacements.
Philips 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
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 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 U.S., Philips does not own or manage the CPAP patient's contact information - many patients purchase their devices through third parties. 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.
To address affected devices, Philips has mobilized the necessary resources across the company to correct the foam component quality issue that we have identified. 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.
Regarding estimated timing, we are working to address this issue as expeditiously as possible. 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.
On September 1, 2021, Philips announced the start of the repair and replacement in the U.S.: Philips starts repair and replacement program - News | Philips.
The replacement of certain affected devices is already underway and Philips anticipates rework of affected devices to commence in the course of this month.
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 per week and we aim to further increase that capacity to 80,000 units per 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 the process. 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 | Philips
We will continue to publish updates at the following dedicated web site for the recall: www.philips.com/src-update"
Center for Medicare and Medicaid Services (CMS)
"CMS is aware of the Philips recall affecting positive pressure airway devices and mechanical ventilators and is working with the manufacturer and others to help remedy the issue. We have been encouraging beneficiaries who own a positive pressure airway device and may be affected by this recall to contact their supplier or Philips to register their devices in order to start the process of getting the device repaired or replaced. Information about the recall, including which specific models are affected by the recall, and how to register a device is located at the manufacturer's website at: www.philips.com/src-update
The beneficiary can also call Philips at 877-907-7508.
We understand that as a result of the number of patients and devices affected by this recall, there may be a delay getting a remediation. Beneficiaries should contact their doctor to determine the most appropriate options for continued treatment. The beneficiary should also contact their supplier to determine how to comply with the doctor's advice.
Beneficiaries should talk with their supplier about any products not impacted by the recall that may be available to meet their needs while they wait for Philips to repair or replace their device. Suppliers should not be charging beneficiaries for any repairs of positive airway pressure devices subject to the recall or replacements of these devices that are less than five years old that is the responsibility of the manufacturer and supplier.
Suppliers are required by Federal regulations to accept return of substandard items and must replace positive airway pressure devices that do not last for the five-year reasonable useful lifetime of the equipment at no cost to the Medicare program or beneficiary.
Under Federal regulations, suppliers must replace the equipment at no charge to the beneficiary or the Medicare program if the equipment doesn't last for the five-year reasonable useful lifetime. In these instances, suppliers should be working with beneficiaries and their physicians to identify and furnish appropriate replacement devices while they wait for the affected equipment to be repaired or replaced by the manufacturer. CMS continues to work with the manufacturer and others in facilitating the remediation process."
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