Issues with ventilators across three major manufacturers—Philips, Baxter and Zoll—have led to a string of Class I recall notices from the FDA, the agency’s most severe level.
First, a serious problem with certain models of Philips Respironics’ BiPAP machines for people with obstructive sleep apnea, available for home use, has been linked to interruptions in therapy—potentially leading to hypoventilation, hypoxemia and respiratory failure. The FDA said it has received reports of 10 injuries and 7 deaths, from among tens of thousands of distributed systems.
The recall effort for the company’s BiPAP V30, A30 and A40 models includes updating their instructions; the devices do not need to be returned to the manufacturer.
According to the agency, a failure in the “Ventilator Inoperative” alarm may cause the machine to reboot intermittently for periods of five to 10 seconds and restart either with the patient’s settings or the factory defaults. The devices may also enter an inoperative state after three reboots within 24 hours.
Philips first notified users of the issue in late March, recommending that patients switch to an alternate device if the problem occurs where possible, and to make sure that the settings are correct—and that an optional hard reboot to restart the machine may temporarily restore function.
Meanwhile, a separate recall notice has focused on Philips’ OLA+ Ventilator, also known as OmniLab Advanced+, designed for hospitals and sleep laboratories—where failures in the “Ventilator Inoperative” alarm have been linked to 15 reported injuries and one death, the agency said. Philips plans to update the approximately 10,000 distributed OLA+ machines with a software patch.
At Baxter Healthcare, the company notified healthcare providers in late May of a potential issue with the battery charger dongles for its Life2000 ventilator, with about 2,500 in use nationwide, which can cause the system to either fail to charge or charge intermittently.
Baxter said the battery chargers should be inspected for damage and replaced if needed, and that patients may continue to use the system once there is confirmation that the battery is charging correctly.
Finally, Zoll Medical is updating the instruction manuals for its 731 series of ventilators, which includes the AEV, EMV+ and Eagle II models. The portable machines are used in hospitals and patient transport.
The company said it will update the operator’s guide and quick reference materials to make it clear how far the ventilator should be placed from an MRI machine, based on the strength of the magnetic field. Previously missing details could lead to users placing the devices too close, potentially triggering ventilator alarms or causing a malfunction, the FDA said. The agency reported no connected injuries or deaths.
Editor's Note: This story has been updated, following the FDA's July 10 correction of its figures regarding the number of injuries and deaths associated with the Philips BiPAP recalls. The agency previously listed 952 injuries and 65 deaths; the updated total is 894 malfunctions, with 10 injuries and 7 deaths.