U.S. regulator linked 561 deaths to the faulty Philips ventilators
The U.S. Food and Drug Administration (FDA) has received 561 reports of deaths that could be linked to the Philips recall of sleep apnea breathing-assist devices, the United States regulator said in updated figures. Since April 2021, it’s received over 116,000 reports of injuries reportedly linked to the insulating foam in the machines breaking down, including 561 deaths.
The total number of reports rose by more than 7,000 since the FDA's last update at the end of June. Those incidents involved 111 cases in which a patient died.
The figures include mandatory reports from Philips and voluntary reports from healthcare providers and people who used the CPAP and BiPAP machines. They list a wide range of injuries, “including cancer, pneumonia, asthma, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain,” the FDA said.
The regulator stressed that this “passive surveillance system” has limitations and cannot be used as proof that the health problems reported are definitely linked to the crumbling insulation foam in the recalled Philips machines.
“The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use,” the FDA said. The reports are, therefore, only one of its data points in its assessment of the Philips medical devices.
In 2021, Philips recalled some 5.5 million of the first-generation DreamStation sleep apnea devices after discovering that the sound-dampening foam in the machines could crumble and enter users’ airways if the wrong cleaning agent was used on the device. The recall has already cost the Dutch medical device company many hundreds of millions, excluding pending damage claims and lawsuits against it.
Philips recently announced that it has stopped selling ventilators and sleep apnea breathing-assist machines in the U.S. as part of a settlement agreement with the FDA. The company set another 363 million euros aside for damages as part of this latest step in the massive recall.
