, according to a recall statement from the US Food and Drug Administration (FDA).
The OLA+ Ventilator is designed for use by individuals with obstructive sleep apnea, breathing problems, and mixed apnea and is approved for children aged 7 years and older, as well as adults.
The recall does not involve removal of the devices from where they are used or sold but does update the instructions for use, and its use without following the updated instructions could result in serious injury or death, according to the statement.
Following an alarm failure, the device may fail in one of two ways: By entering a ventilator inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present) or by entering a ventilator inoperative state without rebooting first.
According to the statement, the alarm issue may be corrected with a software patch, available from Philips, or the company will offer a replacement device for patients until the affected devices are repaired. The statement updates an April 1, 2024, urgent recall from Philips urging the immediate removal of a patient from an OLA+ Ventilator and connecting them to alternative ventilation if possible if the ventilator’s inoperative alarm occurs.
The device failures may cause interruption or loss of therapy with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and even death in especially vulnerable individuals. One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.
US customers can contact Philips Respironics Inc. at 1-800-345-6443 or respironics.clinical@philips.com with questions, according to the FDA, and clinicians and patients may report adverse reactions or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
A version of this article appeared on Medscape.com.