U.S. regulator slaps Philips with another warning over sleep apnea devices
The American regulator FDA has given Philips another warning about problems with its sleep apnea devices. The new warning concerns overheating of the DreamStation 2, which was not included in the massive recall that has cost the Dutch health tech company hundreds of millions since 2021, NU.nl reports. The price of Philips stock fell by nearly 7 percent on the Euronext Amsterdam exchange moments after trading opened.
The FDA has received 270 reports of problems with the temperature of the DreamStation 2 between August and mid-November. The regulator spoke of a “sharp increase.” Reports include fire, smoke, burn marks, and other signs of overheating, the regulator informed Philips.
The FDA advised people using the DreamStation 2 to monitor the machines closely for unusual smells. It also urged them to read the instructions for use carefully.
Philips stock was valued at 18.22 euros per share on Euronext Amsterdam at about 9:20 a.m. on Wednesday. That was about three percent lower than when the market opened 20 minutes earlier, and 6.8 percent lower than when the market closed on Tuesday afternoon.
These reports may signal the start of a new chapter in Philips's years-stretching recall and repair operation with its sleep apnea machines.
In 2021, the Dutch company recalled some 5.5 million of the first-generation DreamStation devices after discovering that the sound-dampening foam in the machines could crumble and enter users’ airways if they used the wrong cleaning agent on the device.
The recall has cost Philips hundreds of millions of euros, and several damage claims and possible settlements are still looming in the United States.
