Philips Continues to Ride the Recall Rodeo

Adding additional wounds to Philips bruising few years dealing with its major recall of CPAP and BiPAP machines, a new issue has arisen in a swath of its CPAP machines not included in the 2021 notice.

FDA today released a safety communication warning consumers about signs of overheating in CPAP machines after Philips turned over 270 medical device reports (MDRs) that complained of thermal issues with the DreamStation 2 CPAP machine, some of which detailed patient injuries like burns. The 270 MDRs were received between Aug. 1, 2023, and Nov. 15, 2023. This is compared to fewer than 30 MDRs received about the device in the previous three years.

“Philips Respironics filed these approximately 270 reports over the last three months which cover a three-year period following a retrospective review of possible thermal complaints related to DreamStation 2 since the launch of the product,” a Philips representative told MD+DI.

The safety communication detailed reports of fire, smoke, burns, and other signs of overheating while people were using the device. The exact cause of the thermal issues is still under investigation by the company and FDA, with the agency noting that a possible underlying cause could “be related to an electrical and/or a mechanical malfunction of the machine, which may cause it to overheat in certain situations,” according to a press release.

FDA is continuing discussions with Philips on mitigation strategies for the safety issue and offered recommendations for patients, caregivers, and healthcare providers. Following the devices’ user manual, FDA said to make sure customers are placing CPAP machines on a firm, flat surface and keeping it away from carpet, fabric, or other flammable materials. It’s important to carefully clean the machine, they said, and to empty its water reservoir. To reduce the risk of burns, it is also recommended to let the CPAP machine’s heater plate and water tank cool for about 15 minutes before removing the tank as burns may occur if the heater plate is touched, or a customer comes in contact with heated water or the humidifier water tank pan.

The safety communication also noted not to use the machine and unplug it if there is a burning smell, smoke, or any unusual odors present, if there is a change in the appearance of the machine, unexplained changes to its performance, water has spilled into the machine, or there are unusual sounds coming from the machine.

Currently, patients can continue to use the millions of DreamStation 2 devices that remain on the market as long as safety instructions are followed. “Philips Respironics conducted review and analysis regarding reports of the possible thermal issues in accordance with its regulatory processes,” Philips said in a statement. “The devices can continue to be used provided that the safety instructions in the instructions for use for the DreamStation 2 sleep therapy device are followed.”

The DreamStation 2 devices were not included in the company’s ongoing CPAP and BiPAP recall which began in 2021 and is still ongoing. However, the device was sent out in specific cases as a replacement for those recalled devices. Additionally, FDA said that the thermal issues detailed in the DreamStation 2 recall don’t seem to be caused by the silicone foam used to muffle sounds and vibrations in certain devices.

The issue of foam relates to the 2021 recall, which was centered on the use of a different foam, made up of polyester-based polyurethane, which was found to be at risk of breaking down over time and potentially releasing chemicals and debris into a user’s airflow. The DreamStation 2 device is the successor of the DreamStation 1, which used the problematic foam.

“We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the agency’s press release. “Addressing these safety concerns remains a top priority for the FDA.”

After the news was announced, Philips saw a major hit to its shares — a decrease of more than 6%.

Philips, however, is not new to the recall rodeo. Since the beginning of the years-long CPAP and BiPAP recall process, the company has seen multiple other recalls — including on its reworked machines — as well as US Department of Justice discussions, a French investigation, a 70% plunge in its market value, and two rounds of layoffs which cut over 10,000 jobs collectively.

The company said it continues to work with FDA to ensure patient safety. “Philips Respironics’ number one priority is patient safety and quality,” a representative told MD+DI.