Dive Brief:
- Philips recalled several models of its Trilogy ventilators because of multiple problems that can result in patients not receiving enough ventilation or oxygen.
- The company is asking users to install a software update intended to fix problems including false power loss alarms, an inaccurate display of the amount of oxygen being delivered to the patient, and oxygen volume measurement inaccuracies. Philips is also now requiring the use of filters with the devices. The recall is intended to fix previously reported and new safety issues, the Food and Drug Administration said in a Tuesday notice.
- Reports of nine injuries and one death were associated with the problems, according to the FDA.
Dive Insight:
Philips’ Trilogy ventilators provide breathing support in medical, home and non-emergency transport settings.
Philips first flagged alarm problems with the ventilators in March. When set for high concentration oxygen therapy, they might indicate a higher value of oxygen than the device is actually delivering, the company warned.
Last year, Philips also warned that dust and debris might block the machines’ vents, impeding airflow.
The latest recall is intended to correct several problems that might affect patient breathing. Those problems include patients receiving less oxygen than indicated on the screen; environmental contamination of the device sensor; and false alarms for power loss or battery depletion. Philips also said it added missing contraindications in the devices’ instructions for use, and fixed translation errors in instruction manuals in Korean, Traditional Chinese and Spanish.
Philips began the recall in July. It applies to the Trilogy Evo, Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal models.
The action affects about 90,000 units worldwide, including about 67,000 in the U.S., a company spokesperson wrote in an email Wednesday.
The spokesperson said there are no new health hazards communicated in the notification.
“The notice indicates how prior field safety notices are being corrected,” the spokesperson wrote. “The notice also includes information on labeling and instruction manual updates. Philips Respironics is also addressing new non-safety issues in these updates.”
Philips said that the ventilators should not be used until the devices’ software has been updated. The company also added a change to the user manual, now requiring the use of a “Philips approved particulate filter” to prevent environmental contamination.
The ventilators were also part of a broader recall of Philips respiratory devices for the use of soundproofing foam that could break down and be inhaled by patients. In April, Philips reached a consent decree with the Department of Justice that involved halting sales of most of its respiratory devices in the U.S. and repairing, refunding or replacing the recalled devices.
However, the company can still manufacture and distribute certain devices the FDA has deemed “medically necessary,” including ventilators and associated accessories. Philips’ Trilogy Evo, Trilogy EV300 and Trilogy Evo Universal ventilators were on the list of medically necessary devices.