Smith Medical Recalls PneuPac paraPAC Plus 300 and 310 Ventilator Kits

Smiths Medical ASD today announced the Class I recall of its PneuPac paraPAC Plus 300 and 310 ventilator kits after receiving complaints reporting continuous positive gas flow instead of the intended cycling like a human breath when switched to the ventilate operating mode.

The PneuPac paraPAC Plus 300 and 310 ventilator kits are gas powered emergency and transport portable ventilators that can be used in vehicles like planes and helicopters and are suitable for use at an accident scene or transport between hospitals or within a hospital. The ventilators can be used to provide ventilatory support for adults, children, and infants over 10 kg. The paraPAC Plus devices can also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients, according to the company via the recall notice. Additionally, the devices can be used in urgent situations for ventilatory support for CPR resuscitation.

Smiths Medical is recalling the devices after receiving reports that the ventilator may “intermittently provide continuous positive gas flow instead of the intended cycling like a human breath when it is switched to the "Ventilate" operating mode,” according to the FDA notice.

This malfunction of non-cycling and continuous positive gas flow when in the cycling mode prevents the device from functioning properly and can result in patients not receiving the right amount of ventilation or enough oxygen. The issue may also cause a complete or partial airway obstruction that could lead to serious injury or death. Currently, Smiths Medical has received 117 medical device reporting events including 8 serious injuries and no deaths. Of note, the recall is categorized as a correction, not a product removal.

On Feb. 7, Smiths Medical sent an Urgent Medical Device Correction Notice to users with information about the situation and recommendations moving forward. The company wrote that there was no need to return or discontinue using the ParaPAC Plus but urged users to follow all instructions, including warnings and cautions in the user manual document with heightened awareness when using the device.

Specific instructions the company urged customers to pay increased attention to include the constant monitoring of patients, independent monitoring of blood oxygenation and expired carbon dioxide levels using pulse oximetry and capnography, performing all pre-use checks before each use, having alternative means of ventilation available in the event of device failure or malfunction, and if the paraPAC Plus ventilator malfunctions, removing it from clinical use, setting the device aside for repair, and using another device or means of ventilation.

Currently, 2,906 devices are included in the recall which were distributed between Jan. 1, 2023, and Sept. 11, 2023.