FDA Receives Over 21,000 Medical Device Reports, Including 124 Deaths, Linked to Philips Foam Outage


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Diving Brief:

  • The Food and Drug Administration published new data on medical device reports associated with the ongoing Philips Respironics sleep apnea and ventilator recall, including more than 100 patient deaths and tens of thousands of total reports.
  • Between April 2021 and April 30, 2022, the FDA received more than 21,000 medical device reports associated with degradation of foam used in noise-dampening machinery, which was the catalyst for the recall of millions of devices from sleep apnea and ventilators. Of the 21,000 reports, there were 124 reports of patient deaths associated with foam breakdown. The data does not specify how many serious injury reports were made during the same period.
  • Medical device reports include both mandatory reports from Philips and voluntary reports from healthcare professionals, consumers and patients, according to the update. The FDA said the reporting system is useful but has its limitations, stating that “the incidence, prevalence, or cause of an event generally cannot be determined from this reporting system alone due to the under-reporting of events, inaccuracies in reporting, lack of verification that the device caused the reported event, and lack of information on how often the device was used.”

Overview of the dive:

The new data comes nearly a year after Philips’ recall, which expanded to include more than 5 million ventilators and sleep apnea devices. The company first publicly acknowledged the product safety issues during an April 2021 earnings call and announced the recall in June.

The recall is due to foam in the machines breaking down and can be inhaled or ingested by users, risking exposure to toxic chemicals.

In March, the FDA ordered Philips to notify all of its distributors, healthcare providers and patients after finding that the company had failed to properly communicate the recall. The agency’s Center for Devices and Radiological Health also proposed a separate order earlier this month that would require Philips to submit a repair and replacement plan for affected devices.

Along with the 124 death reports, the FDA said a wide range of injuries had been reported, including cancer, pneumonia, asthma, infections and chest pain.

“The FDA remains committed to ensuring that patients and providers have timely information about recalled devices. In addition to our recent notice to the company, we continue to closely monitor reports and the risk posed by foam,” CDRH Director Jeff Shuren said in an emailed statement Thursday. “Our recommendations to patients and providers remain unchanged at this time and we will continue to provide updates as we gather and analyze additional information, including any further action related to this recall.”

The more than 21,000 medical device reports between April 2021 and April 30, 2022 represent a jump from the previous 10 years.

Between 2011 and April 2021, Philips filed 30 medical device reports with the FDA due to noise-canceling foam issues with no reports of injuries or fatalities, according to a statement emailed by the company. Following the acknowledgment of the safety issues in April 2021 and the June recall announcement, Philips “has received a large increase in complaints allegedly associated with possible foam degradation”.

Like the FDA, Philips says “the cause of an event generally cannot be determined from this reporting system alone,” adding that the company investigates all allegations of patient death and injury. serious and on reports of device malfunctions.

“Philips regrets any inconvenience caused by this issue and we are committed to supporting the patient community who rely on our sleep and respiratory care solutions for their health and quality of life, and the physicians and customers who are dedicated to meet patient needs,” the company said in a statement Friday. “We are replacing or repairing Respironics Field Action-related devices as quickly as possible and continuing to update patients and customers on program progress.”

Philips also noted that it had tested the potential health risks of using devices. In December, the company argued that exposure to volatile organic compounds in certain recalled machines is not generally associated with long-term health consequences.

During an earnings call in April, Philips told investors that the company and its subsidiaries had been subpoenaed by the US Department of Justice for information about the recall. Phillips put aside 885 million euros (about $934 million on Friday) to meet the recall, according to the company’s statement.


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