Dive Brief:
- Smiths Medical is recalling more than 2,900 emergency ventilators in the U.S. after receiving reports of a fault linked to eight serious injuries, the Food and Drug Administration said Thursday.
- The fault can cause patients to receive the wrong amount of ventilation or too little oxygen, as well as a complete or partial airway obstruction. The FDA categorized the event as a Class I recall because of the risk of serious injury or death.
- Smiths Medical, which has faced a series of regulatory actions in recent years, told customers to continue using the Pneupac Parapac Plus 300 and 310 Ventilator Kits but to take precautions.
Dive Insight:
Healthcare professionals use the gas-powered portable ventilators to provide patients with oxygen at the scene of accidents and during transport, including in vehicles such as airplanes and helicopters. The ventilators can provide free flow oxygen therapy and continuous positive airway pressure therapy to people who are breathing spontaneously and give ventilatory support for CPR resuscitation.
Smiths Medical received 177 reports of a problem with the devices. The ventilators “may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath” when switched to the “ventilate” operating mode, the FDA said.
“This non-cycling and continuous positive gas flow when in cycling mode is a malfunction that prevents the ventilator from functioning properly. As a result of this issue, patients may not receive the right amount of ventilation or enough oxygen (hypoventilation),” the FDA said. “The issue may also cause a complete or partial airway obstruction. Any of these occurrences can lead to serious injury or death.”
Smiths Medical sent recommendations to customers in February. The company said to keep using the devices but follow the existing instructions with “heightened awareness.” Smiths Medical highlighted the need to constantly monitor the patient, check their blood oxygenation and expired carbon dioxide levels independently and have access to an alternative means of ventilation.
If a ventilator experiences continuous flow, customers should remove it from clinical use and set it aside for repairs, the company said.
The notice follows Class I recall notifications about Smiths Medical’s Medfusion 3500 and 4000 syringe pumps. ICU Medical acquired Smiths Medical for $2.35 billion in January 2022 and inherited problems including a FDA warning letter.