Smiths Medical recalls thousands of ventilators due to fault linked to 8 serious injuries

Healthcare professionals rely on gas-powered portable ventilators for oxygen administration in various settings, including during transportation and at accident scenes. These ventilators offer free-flow oxygen therapy, continuous positive airway pressure therapy, and ventilatory support for CPR resuscitation in spontaneously breathing patients.

Smiths Medical received 177 reports of issues with their ventilators. The FDA noted that these devices may intermittently deliver continuous positive gas flow instead of cycling as intended when switched to the "ventilate" mode. This malfunction poses serious risks, including inadequate ventilation, insufficient oxygen delivery, and potential airway obstruction, which could lead to injury or death.

In response, Smiths Medical advised continued use of the devices with heightened awareness and adherence to existing instructions. They stressed constant patient monitoring and access to alternative ventilation methods. Should a ventilator exhibit continuous flow, customers are instructed to remove it from clinical use and await repairs. This notification follows Class I recall alerts for Smiths Medical’s Medfusion 3500 and 4000 syringe pumps, highlighting issues inherited by ICU Medical after they acquired Smiths Medical.