Philips has announced the recall of their DreamStation CPAP machines. This device is used for obstructive sleep apnea and is also referred to as BiPAP. The device is made of a small motor that pulls air into the wearer's throat. While Philips has not been linked to any health issues with their CPAP machine, it does have some potential risks that users should know about.
The DreamStation CPAP machines were produced using polyester-based polyurethane sound abatement foam, which could release toxic gases and black debris into the air. These substances could enter the air tubing and inhale by the wearer, and pose a risk to users. Philips has issued a voluntary recall and has plans to replace the foam.
During the recall, Philips contacted consumers who received recalled devices. They will continue to notify customers as they receive new information. Consumers will be able to register for a free replacement device, and Philips will cover the cost of shipping the device back to them. Users can also sign up for a priority program if they have a documented medical need. However, priority access does not guarantee that a replacement will be available faster. If you are concerned about your safety, you should consult with a doctor.
For consumers who have questions about the recall, they can contact the FDA. The agency has a webpage with additional resources. Their website has a section titled, "What is a Medical Device Recall?" It contains information on how to identify a recalled product and what steps to take if you have a recalled device.
Additionally, the company has begun a repair process and is working with regulatory agencies to find a solution to the issue. Philips will determine the number of devices in use and will notify consumers when the replacement is ready for shipment. They plan to have the program completed within twelve months.
In the meantime, Philips is offering free repairs on their DreamStation CPAP machines. You can contact the company for more information, or you can use their patient portal to get updates on expected shipping dates. During the recall, Philips contracted with a third-party vendor to help coordinate the repair effort. Until Philips's repair efforts are complete, it is recommended that users not open the devices and only clean them in the manufacturer's approved methods.
Philips is currently running tests on other CPAP devices to find out what caused the problems with their products. These tests are being conducted by independent researchers. The findings are being reviewed by the FDA.
Philips will also provide a box to send your device to them. Alternatively, you can contact the company and have them send you a return label. Once you receive the label, you should follow the instructions to return the device.
Depending on your health needs, your doctor may recommend switching to a different brand or model such as ResMed AirSense 10 Autoset. There are other possible treatments for sleep apnea, including jaw realignment and oral appliances. Patients who have experienced other health problems associated with their device should discuss their symptoms with their doctors.
