Sleep Apnea Patients Beware: Philips DreamStation Recall Could be Life-Threatening
This past weekend, my family got together and and at some point we all discussed the differences between each one of our sleep studies.
I come from a long line of snorers apparently and I seem to be carrying on the tradition to the dismay of my wife.
So, CPAPs are commonplace, unfortunately, in my family and most likely yours.
What Are CPAPs and BiPAPs?
Continuous positive airway pressure (CPAP) machines provides a steady stream of air at a continuous pressure through a mask. This helps to keep the airway open during sleep for people with obstructive sleep apnea.
Bilevel positive airway pressure (BiPAP) machines pump air into the lungs under varying pressure. They use higher pressure when the person inhales and lower pressure when they exhale.
Philips Respironics has issued a Class I recall of certain reworked DreamStation CPAP and BiPAP machines due to the duplication of serial numbers during initial programming, which can result in therapy being delivered using the wrong prescription or factory default settings.
This recall affects 1,088 devices in the United States that were distributed from December 1, 2021, to October 31, 2022.
This error can cause therapy failure, and there is no warning or indication to the user that the device is not working as intended. Incorrect therapy or therapy failure can lead to respiratory failure, heart failure, serious injury, and even death.
Who May be Affected and What to Do
Philips has advised affected customers and patients to locate the serial number of their device and verify it against the serial numbers noted in the recall notice.
According to the FDA website Philips DreamStation users should:
- Continue to use the current device until a replacement device is received or until pressure changes are made by your provider on the current device.
- Contact your provider to ask about getting a manual reset of pressure either remotely or in person (fastest).