Updated 4/11/23 with comments from Philips
Philips Respironics is recalling certain reworked DreamStation CPAP and BiPAP machines for the risk that they may deliver inaccurate or insufficient therapy.
The product being recalled is Philips Respironics DreamStation1 (Uno Remediated Devices), models REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto CPAP, DOM – RECRT.
1,088 of these devices were distributed from Dec. 1, 2021, to Oct 31, 2022. This recall is for certain reworked DreamStations that were also recalled in June 2021.
According to information from the US Food and Drug Administration (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.
Incorrect therapy or therapy failure may lead to several health conditions, such as respiratory failure, heart failure, serious injury, and death.
Philips has received 43 complaints about this issue. There are currently no reported injuries or deaths.
The FDA has identified this as a Class I recall, the most serious type of recall.
In an emailed statement to Sleep Review, Philips states, “In early February 2023, Philips Respironics issued a product notice related to a specific number of remediated first-generation DreamStation CPAP devices in the U.S. and France. An identified, limited amount (~1,200 units) of remediated first-generation DreamStation CPAP devices had been incorrectly programmed with either an incorrect serial number or a duplicate serial number, resulting in communication issues with the Care Orchestrator care management software. This may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient. As a result, patients may find the device provides different pressure and comfort settings than the patient is accustomed to.
“Affected devices may continue to be used in accordance with device instructions for use. At the time of this notification, Philips Respironics has not received reports of patient harm.“
Who May be Affected
- People who receive breathing support from the affected DreamStation machines
- Health care providers and in-home caregivers who provide care for patients who use DreamStations for breathing support
What to Do
On Feb. 10, 2023, Philips sent affected customers and patients an Important Product Notice with the following recommendations. Products can be identified by locating the serial number of the device and verifying it against the serial numbers noted in the letter.
Via email to Sleep Review, Philips Respironics states it is reaching out to patients to set up replacement and return of affected devices. “No further action is necessary by patients. To date, we are more than halfway with the shipments of replacement devices to patients.“
For Users and Patients
- 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).
- Provide the enclosed letter to affected patients.
- Replacement product will be provided to customers for exchange of affected devices.
- Philips is attempting to contact all users and/or patients by phone to set up pressure changes or replacement and return of affected devices.
“This matter does not impact the remediation of sleep therapy devices under the June 2021 field safety notice,” Philips states. “We regret the concern that this field safety notice for specific sleep therapy and ventilator devices have caused for patients and care providers. Following the substantial ramp-up of capacity, Philips Respironics has now produced the replacement devices and repair kits required for the remediation of the registered affected sleep therapy devices globally.”