Shares of Philips Electronics NV were losing around 5 percent in Amsterdam trading as well as in the pre-market activity on the NYSE after the U.S. regulator warned against the safety of Dutch consumer electronics giant’s DreamStation 2 Continuous Positive Airway Pressure or CPAP Machines.
The Food and Drug Administration or FDA said it is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 CPAP machines used for treatment of obstructive sleep apnea.
The warning follows the recently received medical device reports or MDRs associated with issues, such as fire, smoke, burns and other signs of overheating while using the machine.
The FDA said it is in ongoing talks with the company about mitigation strategies for the safety issue.
The safety communication was issued to inform the public of reports involving thermal issues with the machine, some of which cited patient injuries. The agency also provided safety recommendations for patient use, including carefully monitoring machines for signs of overheating.
The device was cleared for marketing on July 10, 2020, and prior to August 1, 2023, the agency had received fewer than 30 MDRs associated with thermal issues with the device. However, between August 1, 2023 and November 15, 2023, the FDA received more than 270 MDRs associated with thermal issues of the machine.
According to the FDA, the thermal issues may be related to an electrical and/or a mechanical malfunction of the machine, which may cause overheating in certain situations.
The agency urged the users of the machine to follow the manufacturer’s instructions in the user manual and to inspect and examine the machine for unusual smells or changes in appearances before and after each use.
The new safety issue comes as the FDA continues to closely monitor Philips’ handling of the June 2021 recall impacting millions of sleep therapy and respirator machines, including CPAP machines.
In Amsterdam, Philips shares were trading at 18.38 euros, down 5.96 percent. In pre-market activity on the NYSE, the shares were at $20.13, down 4.82 percent.
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