Philips BiPAP Recall Issued Due to Risk of Interruptions, Loss of Therapy

This is at least the third Philips BiPAP recall to impact these devices in recent years due to various problems, including risks of device failures and exposure to toxic chemicals

Philips Respironics has issued updated instructions for some of its BiPAP ventilator breathing machines, following reports that some of users are experiencing interruptions and loss of therapy, which federal regulators have classified as the most serious type of recall after Philips revealed that dozens of patient deaths may have been caused by the problem.

The U.S. Food and Drug Administration (FDA) announced the Philips BiPAP ventilator recall on June 27. Though the devices are not being removed from the market, the agency reports that it has given the action a Class I recall designation, indicating that problems with the devices present a serious risk of injury or death to patients.

According to the recall notice, the V30, A30, and A40 BiPAP devices have a Ventilator Inoperative Alarm that could fail, which could prevent patients from receiving life-sustaining oxygen. If this happens, patients could suffer hypoventilation, hyoxemia, hypercarbia, respiratory failure or death.

The problem has resulted in 952 reported injuries, and 65 reports of patient deaths.

Philips Breathing Device Problems

The BiPAP recall comes as the manufacturer is still reeling from problems which led to a recall of several million Philips CPAP, BiPAP and ventilator machines distributed between 2009 and April 2021.

Some of the recently recalled Philips BiPAP machines were also included in this earlier action, which impacted machines distributed with a PE-PUR sound abatement foam  found to break down over time, releasing toxic black particles into the air pathways, tubing, mask and users lungs.

In addition, the same ventilators were included in a 2022 Philips BiPAP machine recall, due to the release of toxic chemicals from its plastic components. This recall also resulted in an FDA Class I designation.

In March, Philips sent an Urgent Medical Device Recall notice to its customers, which called for a change in the instructions on how to use the devices. The company warns that when the devices malfunction, they may reboot intermittently for five to 10 seconds, then restart with the same patient settings. They may also restart back to the original factory settings, or enter into a Ventilator Inoperative state, stopping therapy after three reboots within 24 hours, or after no reboots at all.

Philips Respironics, Inc. indicated that patients should be immediately removed from the affected devices if the Ventilator Inoperative Alarm occurs, and switched to an alternative source of ventilation, if one is available.

The letter also suggested operators can attempt to perform a “hard reboot” of the device to force it to restart, which could temporarily restore device function. These updated instructions and warnings have been classified as a Philips BiPAP recall.

The action impacts Philips BiPAP V30 Auto devices with model number 00606959049635; BiPAP A30 devices with model number 00606959039308; and BiPAP A40 devices with model number 00606959039476.

Customers with questions should contact Philip Respironics, Inc, as 1-800-345-6443, or via email at respironics.clinical@philips.com.

Philip CPAP Recall Lawsuits

Philips Respironics has been plagued by recalls in recent years, and has faced sharp criticism from regulators over it’s handling of a massive 2021 recall, which also affected DreamStation CPAP devices and other breathing assistance machines.

As a result of problems linked to that earlier recall, thousands of Philip CPAP lawsuits have been filed by former users left with severe lung damage, respiratory injuries and other injuries, and the FDA has identified serious deficiencies in the company’s recall and repair program, which has further increased the risks faced by owners of the machines.

The FDA repeatedly warned that the company was failing to properly repair and replace the recalled units, announcing a consent decree earlier this year that barred Philips from manufacturing and distributing CPAP and other breathing assistance devices in the U.S. until the company shows it can meet requirements set by federal regulators.

In September 2023, Philips announced it will pay at least $445 million in a CPAP recall class action settlement to individuals who bought, rented or leased one of the impacted devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines.

To resolve personal injury and wrongful death lawsuits, the company also announced a $1.1 billion Philips CPAP recall settlement agreement in April 2023, effectively ending litigation over problems linked to the defective sound abatement foam at issue in the 2021 recall.