UPDATE: July 11, 2024: The Food and Drug Administration on Wednesday corrected the number of injury and death reports associated with Philips’ recall of bilevel positive airway pressure (BiPAP) machines. The agency now says there are 894 malfunctions, 10 injuries and seven deaths associated with a false alarm problem that can cause the machines to shut down. The FDA reported much higher numbers of injuries and deaths on June 27.
An FDA spokesperson wrote in an email the agency determined that the previous figures were based on an “incomplete analysis.”
“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 issue that were classified as ‘Malfunction’ but were not alleged to have caused an injury or death,” the spokesperson wrote.
The agency’s figures now match those Philips provided.
UPDATE: June 28, 2024: Philips spokesperson Lu Yu wrote in an emailed statement that Philips does not recognize the number of reported injuries and deaths in yesterday's FDA notice, and is in dialogue with the agency. The company said it has received reports of 10 serious injury and seven deaths over a 12-year period between 2011 and 2023 for the A30 and A40 devices. No reports of serious patient harm have been reported with the V30 devices, Philips said.
Philips’ recall of bilevel positive airway pressure (BiPAP) machines has now been linked to reports of 952 injuries and 65 deaths, according to a Food and Drug Administration notice posted Thursday.
Philips began a recall of its V30, A30 and A40 BiPAP machines in March because a false alarm can cause the devices to shut down. The company updated its instructions for use, but is not removing the affected devices from use or sale.
The FDA posted the recall to its database in May. At the time, Philips said it had received 10 reports of injuries and seven reports of death associated with the problem.
The company did not answer MedTech Dive’s question as to why the number of reports had increased in the last month.
“There have been reports of potential patient harm. Investigation of these reports could not conclusively determine causation,” Philips spokesperson Ben Zwirs said in an emailed statement.
The recall applies to about 100,000 units, Zwirs wrote. Under certain circumstances, the devices’ ventilator inoperative alarm may incorrectly engage, causing the ventilator to shut down.
Philips said in the updated instructions that a patient should be placed on an alternative device if an alarm occurs. If interruptions to therapy can’t be tolerated, then patients and caregivers should provide ventilation from another source and contact their equipment supplier for an immediate device alternative.
Philips is investigating the problem and “will implement appropriate actions,” Zwirs added.
The V30 machines, which are used in institutions or hospitals to treat adults and children with obstructive sleep apnea and respiratory insufficiency, were distributed in the U.S., according to an FDA database entry. The A30 and A40 Pro ventilators can be used in home and clinical settings, and were largely sold outside the U.S., according to the FDA.
Philips is restricted from selling many sleep and respiratory products in the U.S., per the terms of a consent decree it struck with the Department of Justice and FDA earlier this year. The company previously recalled the BiPAP machines in 2022 because they contained contaminated plastic and in 2021 because they contained soundproofing foam that could break down and be inhaled.
Editor’s note: The FDA corrected the number of injuries and deaths associated with the recall. The agency now reports 10 injuries and 7 deaths related to the problem.
