FDA Ups Deaths Linked to Philips Ventilator Alarm Failure

The US Food and Drug Administration (FDA) has updated its information related to recalls of the Philips Respironics, Inc. OmniLab Advanced+ (OLA+) Ventilator to reflect an increased number of deaths from one to seven, according to a corrected recall summary. 

The recall involves multiple OLA+ devices, including the BiPAP V30, BiPAP A30, and BiPAP A40 machines. A full list of affected devices is available at the end of the updated recall statement on the FDA’s website. 

“The number of injuries and deaths reportedly associated with this Philips recall have been reevaluated and corrected in the recall summary,” according to an FDA spokesperson. “Upon further review, the FDA determined that the original numbers posted in the recall summary were based on an incomplete analysis the agency had performed of the MDRs reportedly associated with these recalls. We regret the error, and it has been corrected,” the spokesperson said in a statement.

As of July 10, 2024 the FDA noted 911 reports associated with the recall issue (ventilator inoperative), including 894 malfunctions, 10 injuries, and seven deaths.

The recall was prompted by failure of the ventilator inoperative alarm in the devices that may cause interruption or loss of therapy. Potential adverse effects noted in a previous Medscape Medical News story include anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and death. The alarm issue may be corrected with a software patch, available from the company, or the company will make a replacement device available for patients until the affected devices are repaired, according to the FDA.

The FDA was prompted to reevaluate the data because it was determined on further review that “the original numbers posted in the recall summary were based on an incomplete analysis the agency had performed of the [medical device reportings] reportedly associated with this recall,” an FDA spokesperson told Medscape Medical News.

“The previous figures included reports of events that were not associated with the specific reason (ventilator inoperative) for this particular Philips recall, and also included reports associated with the recall issuethat were classified as ‘Malfunction’ but were not alleged to have caused an injury or death,” the spokesperson said. 

For more information, the FDA advises referring to the recommendations listed in the recall summary. “The FDA will keep the public informed if significant new information becomes available,” the spokesperson told Medscape Medical News.

Clinical Reaction

In practice, as clinicians continue to get more information, it would be helpful to follow the recommendations in the recall notice, said Saiprakash Venkateshiah, MD, of Emory University, Atlanta, Georgia, in an interview.

“Clinicians also should have a low threshold to discontinue the use of these devices if they believe the risks outweigh the benefits to their patients,” said Venkateshiah, who serves on the editorial board of CHEST Physician and whose research interests include sleep medicine. He advised erring on the side of caution. “Patients whose clinical condition is not stable enough to tolerate treatment interruption are at higher risk for complications and ideally should not be on these devices,” Venkateshiah told Medscape Medical News.

Additional research is needed to improve the safety of these devices, particularly with better engineered designs that include redundant backup systems in case of failure of one aspect of the device, Venkateshiah noted.

Venkateshiah had no financial conflicts to disclose.