More Noteworthy Updates to the Ongoing Philips Respironics Recall
In 2021, CPAP users were shocked to learn of a wide-ranging recall from Philips Respironics that affected over 5 million devices. At No Insurance Medical Supplies, this resulted in our discontinuing the sale of products that had been affected by the recall.
At the time, Philips Respironics indicated to its customers that they should contact the company to get replacement equipment — but that replacement process has been anything but smooth.
Now, the Philips Respironics recall process has been dealt another blow after the FDA issued a Class 1 recall for repaired Philips Respironics DreamStation 1 devices.
Why the Latest Recall?
According to a statement from the FDA, “Some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed.”
Thus far, the FDA has received 43 complaints about this problem affecting the repaired DreamStation 1 devices. Though no injuries or deaths have been reported with these complaints, the FDA notes that therapy failure can potentially lead to serious conditions, including heart failure and respiratory failure. As a Class 1 recall, the FDA judges this as the most serious type of recall, where continued use of the affected devices could result in serious injury or death.
Philips estimates that roughly 1,200 repaired CPAP devices were affected by the incorrect programming, and it has begun notifying patients whose CPAP devices are influenced by the latest recall. Users are asked to compare the serial number on the bottom of their CPAP machine to the serial numbers listed in the letter from Philips Respironics to determine if their device is affected. Medical providers can also assist in manually resetting the treatment settings for the affected devices to ensure proper treatment.
A Refresher on the Original Recall
The original Philips Respironics recall was linked to foam degradation and chemical exposure from the foam in several of its CPAP and BiPAP devices, including the popular DreamStation line (including the portable DreamStation GO), as well as its System One 50 and 60 series, and other devices.
As per the original recall, foam inside these devices could degrade into smaller particles that could then get inhaled or ingested by a person using the CPAP machine. The sound abatement foam was also found to have the potential to emit volatile organic compounds, exposing users to harmful chemicals such as dimethyl diazine.
This type of exposure had the potential for airway inflammation and toxic carcinogenic effects, as well as adversely affecting other organs like the liver and kidneys.
Philips originally reported that the issues with the foam were likely linked to using their CPAP machines in higher humidity and temperatures, while also pointing some blame to the use of ozone and UV light cleaning devices. Unsurprisingly, these claims have seen significant pushback from the manufacturers of CPAP cleaning devices, including lawsuits.
Additional Recall Problems
According to a report from CBS, the new recall is just the latest in a string of problems that customers affected by the original recall have experienced. The FDA has received over 98,000 complaints related to the original recall, with patients linking their use of the device to cancer, pneumonia and other respiratory problems, chest pain, and more. The foam problems have also been linked with 346 deaths.
Despite Philips Respironics’ efforts to replace the affected devices, many patients report being left out — the CBS report cites one patient who has filed a lawsuit against the company because she still hasn’t received a replacement for her device after two years.
In December 2022, the FDA also issued a recall for reworked Trilogy 100 and Trilogy 200 ventilators because of silicone foam adhesion failures and exposure to residual foam debris. This recall is also a Class 1 recall.
Notably, while Philips Respironics’ page for the recall states that “90% of the production of replacement devices and repair kits globally has been completed,” it also notes that only 2.46 million replacement devices and repair kits have been shipped within the U.S. This means a significant number of individuals still have not received a replacement device.
If you use a Philips Respironics device and are worried about whether you are affected by these latest recall updates, you should contact Philips directly. This can be done via their web portal, by calling 1 (800) 387-3311, or emailing firstname.lastname@example.org. This is the way you should process your recalled devices, regardless of whether you bought them through No Insurance Medical Supplies or someone else.
By contacting Philips directly, you should be able to get the most up to date information on the status of your device and its replacement.
Of course, as this process has gone on and continued to have additional problems, we understand how you could be stressed about getting adequate treatment for your sleep apnea. Consulting with your doctor can help you evaluate what your best course of action is for continuing sleep apnea therapy.
If you decide to purchase a new CPAP machine from a different brand, No Insurance Medical Supplies can help. Our best price guarantee ensures heavily discounted rates on popular CPAP machines from leading brands like ResMed and 3B Medical. With free shipping on most orders of $99 and over and available financing, getting a replacement device doesn’t have to break the bank.
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