The FDA issued a notice labeling the recall of certain Philips (NYSE:PHG) Respironics Trilogy and Garbin ventilators as Class I, the most serious kind
This recall relates to the Philips Respironics Trilogy 100, Trilogy 200 and Garbin Plus ventilators. Its impact does not extend to the massive, ongoing CPAP and BiPAP recall.
Here’s a timeline of how the recall unfolded.
Philips also recalled the Trilogy and Garbin ventilators affected by this issue in June 2021, when its Respironics recall began. This recall covers certain reworked ventilators with adhesive issues. The reworked or replaced CPAP and BiPAP machines do not use adhesive to hold the silicone foam in the devices.
In November 2022, Philips warned that reworked Philips Respironics Trilogy ventilators have two new potential issues. The company said the Trilogy 100/200 ventilators with potential additional problems make up roughly 3% of the 5.5 million respiratory devices in the original recall. That amounts to approximately 165,000 devices.
A Philips spokesperson said in an email that the issues in the latest FDA notice relate to approximately 20,000 repaired Trilogy 100.200 ventilators. More than half are in the U.S. The repair of these devices remains paused as Philips develops a permanent corrective action.
“It is important to note that this does not affect any of the CPAP or BiPAP sleep therapy devices that have been remediated which represent the vast majority of the devices affected by the Philips Respironics field safety notice of June 2021,” the spokesperson wrote. “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.”
About the latest update from Philips and the FDA
The FDA notice includes devices distributed between March 1, 2022, and Sept. 6, 2022. Devices recalled in the U.S. total 13,811 since Philips initiated the recall on Dec. 7, 2022.
Affected Trilogy and Garbin ventilators provide breathing assistance to both pediatric and adult patients. Their uses extend to both homes and healthcare settings.
Philips determined that the silicone sound abatement foam installed to replace the PE-PUR foam that initially caused the recall may separate from the plastic backing due to adhesive failure. This foam may potentially move and block the airpath, possibly reducing airflow in the ventilator. It may also cause the device to alarm.
This could result in trouble breathing for a patient, which could be life-threatening.
Additionally, Philips observed residual PE-PUR sound abatement foam in some reworked ventilators returned to customers. Further exposure to PE-PUR foam may cause potential health risks.
Philips said that, as of Jan. 4, 2023, it received 82 medical device reports (MDRs). The company said 63 related to foam delamination and 19 related to particulate debris contamination. It received no reports of death to date.