In November, about a year and a half into its recall of 5.5 million respiratory devices—and well into a subsequent repair-and-replace program for the affected devices—Philips disclosed that it had identified two potential issues in some of the newly refurbished ventilators.
Since then, those concerns have escalated into a voluntary second recall of those devices, and, this week, the FDA announced that it has given the latest safety event its most serious Class I rating.
The re-recall covers a total of 21,345 ventilators around the world that were included in the original June 2021 recall and were repaired between March and September of 2022, according to entries in the agency’s recall database. They include several models of Philips’ Trilogy 100 and 200 ventilators as well as one Garbin model currently in commerce.
The original recall stemmed from the inclusion of a polyester-based polyurethane (PE-PUR) foam to muffle sound and vibrations in many of Philips’ ventilators and CPAP and BiPAP machines. The foam was found to be at risk of breaking down over time, potentially sending chemicals and bits of debris into a user’s airflow.
Though Philips quickly moved to replace the PE-PUR material in the affected devices with a new, silicone-based alternative, the company has since found that some of the reworked ventilators may still contain remnants of the PE-PUR foam. As the FDA noted, “Further exposure to PE-PUR foam may cause potential health risks, which can result in serious injury, cause permanent impairment and require medical intervention to prevent permanent injury to users.”
As of the end of 2022, the FDA and Philips have tallied up more than 98,000 complaints sparked by the original recall, including 346 reports of death, though both note that reports of injuries are voluntarily submitted and have not been verified as actually linked to the source of the recall.
“The vast majority (93%) of the approximately 99,000 [medical device reports] filed since April 2021 up to and including December 2022 are alleged technical malfunctions that do not involve serious injury,” Philips said in a statement this month. “Philips Respironics investigates all allegations of technical malfunction serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in certain of these MDRs.”
The other issue behind the new recall is linked to the replacement silicone foam. In some cases, the adhesive that sticks the foam to its plastic backing within the ventilator may fail, causing the foam to separate from the backing. The loose foam could then potentially move into the machine’s airway, reducing or blocking the user’s airflow and triggering a device alarm.
As of the beginning of January, according to the FDA, the two issues found in the reworked devices have sparked another 82 complaints, about three-quarters of which stem from the adhesive issue. No deaths have been reported related to the new concerns.
In a letter (PDF) about the recall sent to healthcare providers in December, Philips recommended that they consider transitioning ventilator-dependent patients using one of the affected machines to another life-support ventilator if possible. For all other uses of the devices, clinicians should ensure that the recalled devices’ alarms are properly configured, set up backup monitoring devices if needed and keep an alternative machine on hand just in case.
According to a company statement sent to Fierce Medtech on Friday, “The repair of Trilogy 100/200 ventilators remains paused as Philips Respironics is developing a permanent corrective action for these two issues in coordination with the relevant regulatory authorities. Once available, Philips Respironics will contact customers to begin the correction process.”
The statement continued, “We deeply regret the concern and uncertainty felt by patients who depend on these devices for their health and well-being. We take the remediation very seriously, and our colleagues are working very hard to get a resolution to patients as fast as possible.”