UPDATE 2-US FDA says 561 deaths related to Philips machines since 2021
(Adds company's response in paragraphs 3 and 5)
Jan 31 (Reuters) - The U.S. Food and Drug Administration said on Wednesday there have been 561 deaths reported since 2021 related to the use of Philips' recalled ventilators and machines for treating obstructive sleep apnea.
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
"Philips Respironics received and continues to receive device associated complaints that have subsequently been filed as medical device reports with the U.S. health regulator," the company said.
The FDA said the medical device reports had limitations and the incidence or cause of an event cannot typically be determined from this system alone due to under-reporting of events, inaccuracies and lack of verification that the device caused the events.
"Philips investigates all received complaints and allegations of malfunction, serious injury or death...and has found no conclusive data linking these devices and the deaths reported," the company said.
The company faces cases brought by patients who said their health has suffered due to the use of the devices, and also following the outcome of an investigation by the U.S. Department of Justice into the handling of the recall.
Earlier this week, Philips said it would not sell new devices to treat sleep apnea in the U.S. in the coming years as it works to comply with a settlement with the FDA.
Philips said it had reached what is known as a consent decree that spells out the improvements it needs to make at its Respironics plants in the U.S.
The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks. (Reporting by Christy Santhosh and Pratik Jain in Bengaluru; Editing by Krishna Chandra Eluri and Shilpi Majumdar)
