Philips Recalls Repaired Trilogy and Garbin Plus Ventilators Over Problems with Replacement Sound Abatement Foam

While Philips Respironics continues to repair millions of recalled ventilators, CPAP machines and BiPAP machines with a silcone-based sound abatement foam, federal regulators have announced a new recall impacting certain repaired Trilogy ventilators and Garbin Plus ventilators, indicating that there may be a risk of the new foam material coming loose, and remnants of the old, toxic foam may still pose a serious health risk for patients.

On February 16, the U.S. Food and Drug Administration (FDA) announced it was giving Class I recall status to a Philips Trilogy and Garbin Plus ventilator recall first announced in December, warning that the new silicone sound abatement foam has reportedly suffered adhesion failures, which could cause airflow blockages in the ventilators. The classification means the agency believes these problems could lead to serious injuries or patient deaths.

Philips Breathing Machine Recalls

Millions of recalled Philips breathing machines sold since 2009 were pulled from the market last year, following widespread reports of small black particles from a polyester-based polyurethane (PE-PUR) being found in the tubing and face masks. Although the foam was intended to reduce noise and vibrations while the machines were used, the FDA warned that the PE-PUR foam may release a number of toxic chemicals and gases directly into the machine’s air pathways.

As a result of the potential CPAP foam health risks, federal health officials indicated that all consumers should immediately stop using the recalled machines, unless needed for life-sustaining therapy, and a widespread Philips repair and replacement program was launched to remove the PE-PUR foam from machines and substitute a silicone-based foam. However, this latest Philips recall impacts certain previously repaired ventilators.

The new recall comes as the manufacturer already faces thousands of Philips CPAP lawsuits brought by former users of recalled machines, who have been diagnosed with certain types of cancer, lung damage and other side effects from the small foam particles entering their mouth and lungs.

Approximately 13,811 repaired Philips Trilogy 100, Trilogy 200 and Garbin Plus ventilators that were reworked after the June 2021 recall are now being recalled once-again.

According to the notice posted by the FDA, the silicone sound abatement foam used to replace the toxic PE-PUR foam in the ventilators may separate from its plastic backing due to failure of the adhesive used to hold it in place.

“The silicone foam material may potentially move and block the airpath, which may reduce air flow in the ventilator and could cause the device to alarm,” the recall notice warns. “If an alarm is not recognized or acted upon, the patient could experience trouble breathing, such as asphyxia, hypoventilation, or hypoxemia, which can be life threatening.”

In addition, Philips found residual PE-PUR sound abatement foam in some of the ventilators which were “repaired” and returned to customers, which could cause potential health risks to patients.

The FDA reports that as of January 4, 2023, the recalled ventilators have been linked to at least 63 reports of foam delamination and 19 reports where PE-PUR foam debris was found inside the machines.

A safety communication about the problems was initially released in December 2022, but the agency now considers this action a Class I medical device recall, suggesting that continued use of the repaired Philips machines may pose a risk of serious injury or death.

Philips CPAP Recall Repair Problems

In September 2021, Philips announced a CPAP machine repair and replacement program, but the pace of repairs has been extremely slow and there have been some concerns about the safety of the alternative foam material the manufacturer is using, which may also release harmful chemicals directly into the machine’s air pathways.

The FDA has criticized Philips handling of the recall, indicating that the company has not done enough to warn consumers about the health risks associated with continuing to use recalled CPAP machines.

Earlier this month, the FDA that it has received nearly 100,00 medical device reports involving problems with Philips CPAP, BiPAP and ventilator devices, including reports of nearly 350 deaths.

February 2023 Philips CPAP Recall Lawsuit Update

Given common questions of fact and law raised in product liability lawsuits filed throughout the federal court system against Philips, a multidistrict litigation (MDL) has been established before U.S. District Judge Joy Flowers Conti, in the Western District of Pennsylvania, who is presiding over coordinated discovery and pretrial proceedings to establish which specific injuries are caused by exposure to the foam, and the average Philips CPAP settlement amounts each individual plaintiff should receive.

On February 6, Judge Conti issued a pretrial order (PDF) which schedules monthly status conferences throughout the year on the following dates:

• April 20, 2023
• May 24, 2023
• June 15, 2023
• July 20, 2023
• August 17, 2023
• September 21, 2023
• October 19, 2023
• November 16, 2023
• December 14, 2023

As part of the coordinated management of the litigation, it is expected that Judge Conti will establish a “bellwether” process, where the parties will identify small groups of representative claims to prepare for early trial dates, which are designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the proceedings. However, if Philips CPAP machine settlements are not reached in the MDL, each claim may later be remanded to different U.S. District Courts nationwide for separate trial dates in the future.