Deaths Linked to Philips BiPAP Machines Lead to Updated Use Instructions

Philips BiPAP recall comes on the heels of a $1.1 billion settlement reached earlier this year, to resolve claims over a separate issue with defective sound abatement foam in other CPAP, BiPAP machines.

Follwing at least eight patient deaths linked to Philips Respironics BiPAP ventilators, a Class I recall has been issued to update the use instructions and provide critical information about problems that may result in the interruption of therapy.

The U.S. Food and Drug Administration (FDA) announced the Philips BiPAP instructions update on August 4, indicating that the Ventilator Inoperative alarm may fail, resulting in interrupted or halted therapy.

The recall affects Philips BiPAP A30, A40 and V30 ventilators, which are commonly used to provide non-invasive breathing support for adults and children over 22 pounds with conditions like obstructive sleep apnea or respiratory insufficiency.

The V30 Auto is typically used in hospital or institutional settings and can also assist patients during transport within a facility, though it is not intended for life support. The A30 and A40 models are used in both home and clinical environments, but like the V30, they are not designed to sustain life in emergency scenarios.

The FDA warns that if the Ventilator Inoperative alarm fails, patients may experience an unexpected loss or interruption of therapy. This can happen if the device reboots multiple times within a 24-hour period or unexpectedly enters an inoperative state without prior warning.

Such interruptions in therapy can have serious consequences, particularly for vulnerable patients. Reports have linked the alarm failure to at least 13 injuries and eight deaths, with outcomes including hypoventilation, low blood oxygen (hypoxemia), elevated carbon dioxide levels (hypercarbia), respiratory failure and even death.

An urgent recall notice was issued to customers on March 19, 2024, instructing that if a Ventilator Inoperative alarm occurs, the patient should be removed from the device and connected to an alternate source of ventilation. 

For patients who cannot tolerate therapy interruptions, caregivers are advised to arrange alternate ventilation immediately and contact their equipment supplier for a replacement device.

The recall notice should be shared with all relevant physicians, clinicians, patients and users. The included response form should be completed and returned.

For more information, customers can contact Philips Respironics, Inc. at 1-800-345-6443 (select prompt 4, then 5), or email respironics.clinical@philips.com.

Philips Ventilator Problems and CPAP Lawsuit Settlements

The latest recall involving Philips BiPAP ventilators adds to a growing list of serious safety concerns linked to the company’s respiratory devices. In June 2021, Philips issued a massive recall impacting more than 15 million CPAP, BiPAP and mechanical ventilators, after it was discovered that a polyester-based polyurethane (PE-PUR) foam used for sound abatement could degrade and release toxic particles and chemicals directly into the airflow.

The deteriorating foam exposed users to potential long-term health risks, including cancer, respiratory problems and organ damage. Many former users reported developing conditions such as lung disease, chronic bronchitis, liver and kidney injuries, heart attacks and strokes. Due to the severity of the issue, federal health officials advised patients to stop using the devices immediately unless required for life-sustaining therapy.

Tens of thousands of Philips CPAP lawsuits were subsequently filed by individuals nationwide, alleging the company failed to warn about the risks and continued to sell defective machines for years. Claims included not only personal injury and wrongful death, but also demands for ongoing medical monitoring and reimbursement for replacement devices.

In April 2024, Philips Respironics agreed to pay $1.1 billion to resolve nearly all personal injury and medical monitoring claims. The settlement followed mediation overseen by Judge Diane M. Welsh and was announced in the company’s first-quarter investor report. While the agreement does not include an admission of liability, it represents one of the largest mass tort settlements in recent years. Payouts are expected to begin in 2025, with $40 million of the total covered by insurers.

This deal came shortly after U.S. District Judge Joy Flowers Conti approved a separate $479 million class action settlement compensating users who purchased, rented or leased affected devices. An additional $34 million will go to insurers and third parties who covered replacement costs. However, that earlier settlement did not cover the thousands of personal injury claims now addressed by the $1.1 billion agreement.

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