Summary: Smiths Medical is recalling its paraPAC Plus 300 and 310 Ventilator Kits due to a malfunction where the device may not cycle properly and instead provide continuous positive gas flow. This issue could lead to insufficient ventilation or airway obstructions, potentially causing serious injury or death.

Key Takeaways:

  • Serious Malfunction Alert: The paraPAC Plus ventilators might fail to cycle correctly, continuously pushing gas, which can obstruct patient breathing and lead to severe health complications.
  • Class I Recall: This is the most serious type of FDA recall, used when there is a reasonable probability of serious health consequences or death.
  • Safety Precautions Emphasized: Smiths Medical has not halted the use of the ventilators but recommends strict adherence to operational guidelines and readiness with alternative ventilation options to ensure patient safety.

Smiths Medical has issued a recall for its PneuPac paraPAC Plus 300 and 310 Ventilator Kits following reports that these devices might intermittently deliver continuous positive gas flow, rather than cycling like human breathing, when set to “Ventilate” mode. This malfunction could prevent the ventilator from operating correctly.

Potential Health Risks

Due to this defect, patients might not receive proper ventilation or sufficient oxygen, potentially leading to hypoventilation. This issue could also cause complete or partial airway obstruction, posing serious risks of injury or death.

Smiths Medical has logged 177 MDR events, including eight reports of serious injuries, with no deaths reported so far. The FDA has designated this as a Class I recall, reflecting the severe risk the device poses to patients.

Usage Instructions and Precautions

Smiths Medical advises continuing the use of paraPAC Plus ventilators but under strict guidelines to ensure safety. Key precautions include:

  • Constant monitoring of the patient
  • Blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography
  • All pre-use checks must be performed before each use
  • Alternative means of ventilation such as bag mask ventilation, must be available in the event of ventilator failure or malfunction
  • If the paraPac plus ventilator experiences continuous flow, remove the ventilator from clinical use, set the device aside for repair and use another device or alternative means of ventilation

Ventilator Description and Applications

The recalled ventilator kits are portable, gas-powered devices designed for emergency and transport use, including in air and ground vehicles. They are suitable for use in diverse environments such as accident scenes, inter-hospital transport, or within medical facilities. The ventilators support patients across all age groups from infants weighing over 10 kg.

In addition to emergency ventilation, the paraPAC Plus devices also provide oxygen therapy and continuous positive airway pressure (CPAP) therapy for patients who can breathe spontaneously. They can also be utilized for CPR resuscitation in critical situations.