Philips PAP Device Recall: Important Update for Summer 2022
People still waiting for a repaired or replaced CPAP (continuous positive airway pressure) machine in the wake of the Philips PAP device recall may be disappointed to learn of further delays.
The manufacturer is providing PAP recall update, saying it has repaired or replaced about half of more than 8 million affected machines globally, far short of Philips’ original September 2022 deadline, which is pushing into 2023.1,2
Philips PAP device recall update
The problem now exceeds the demands originally set by the U.S. Food and Drug Administration (FDA), drawing the attention of the U.S. Justice Department (DOJ). The DOJ sent a proposed consent decree to Philips on July 18.
A consent decree forces a manufacturer to stop all production while resolving quality issues. Analysts say the DOJ may avoid taking this action, given the repair-and-replace backlog and the current worldwide shortage of all PAP devices.3
The CPAP shortage is a result of:1
- Supply chain issues – Certain parts are less available.
- Shipping delays – Deliveries occur at a slow pace.
- Pandemic factors – Millions of machines of all makes and brands were converted into ventilators in 2020. With new Covid-19 variants causing surges of infection worldwide, these machines remain critical for treating severe cases.
- General demand – PAP machine use has risen at a rate of 3 times what manufacturers typically produce.
A medical device recall for the books
The Washington Post described the Philips recall as “one of the biggest medical device debacles in decades.” Indeed, it is a source of endless frustration for people who need CPAP machines.
Millions of people are going without critical respiratory therapy. They have taken their complaints to social media, and there are an increasing number of personal injury and class action lawsuits. Philips has set aside $900 million to handle recall-related expenses, but that did not include potential legal costs.1
About the original recall
Philips discovered that the noise-buffering foam in several of its PAP devices may break down and enter the airway. When using these PAP devices, users may risk inhaling or swallowing debris and chemicals. This may cause anything from headaches to asthma to lung problems and even cancer.4-6
The Class I recall applies to many types of Philips PAP machines manufactured between 2009 and April 25, 2021, including:4-6
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
By July 2021, the FDA reported receiving about 1,200 complaints about problems with the foam, linked to more than 100 injuries. However, in May 2022, the FDA revised that number to 21,000 reports – and 124 suspected deaths, still under investigation – linked to a design concern the FDA believes Philips knew about as far back as 2015.1,6-8
The foam disintegration issues have been potentially linked to high heat and humidity environments and the unapproved use of certain PAP cleaning devices. Recent independent research points to the use of “aggressive ozone-based cleaning products” as the chief cause of foam degradation, according to Philips CEO Frans van Houten.4,9,10
However, the FDA recently found Philip’s data on these cleaning devices “not persuasive” and rejected the company’s argument, suggesting that Philips’ machine design was the likely source of the problem.
The FDA may soon require Philips to submit more details about the logistics of their repair-or-replace program or demand the company issue refunds so PAP users can buy different machines or receive reimbursements for replacement purchases.1
Meanwhile, one PAP ozone cleaning devices manufacturer, SoClean, filed litigation against Philips after claiming it has suffered more than $200 million in losses due to Philips’ accusations about their products.11
What can PAP users do?
Options for PAP users have been limited to:1
- Stopping treatment altogether, risking further health problems
- Purchasing a new machine, sometimes without insurance reimbursement
- Acquiring used machines to continue therapy
- Trying positional therapy to treat sleep apnea
- Working on weight loss to reduce the severity of sleep apnea
Some people are continuing to use their recalled devices, risking health problems. If they haven’t done so, PAP users are encouraged to register their products with Philips to facilitate their repair and replacement.12,13
Waiting for Philips PAP device recall updates too? Was your Philips PAP device recalled? What steps are you taking while waiting for a repaired or replaced device? Click the button below!
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