Today Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices. The recall is in response to potential health risks related to the sound abatement foam component in these devices. The majority of the affected devices are in the first-generation DreamStation product family, but the recently launched DreamStation 2 is not affected by the issue.
Potential Foam Degradation
Philips reports that it has received a low complaint rate (0.03% in 2020). However, Philips determined based on testing that there are possible risks to users related to the type of foam used in these devices. The risks include that the foam may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user. Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals. Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation.
Advice for Patients and Customers
Philips advises patients and customers to take the following actions:
For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or durable medical equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.
For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.
Patients, physicians and DME suppliers can call Philips at 877-907-7508 for additional support.
Philips also has posted additional information for physicians and other medical providers, including a clinical information document.
Repair and Replacement
Philips indicates that it will replace the current sound abatement foam with a new material and has already begun the preparations. Philips plans to address all affected devices as quickly as possible. Philips is creating a registration process that will allow patients to look up their device serial number and begin a claim if the unit is affected.
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