Smiths Medical Revamps Ventilator: Updates for paraPAC Plus Models P300 and P310

Smiths Medical Revamps Ventilator: Updates for paraPAC Plus Models P300 and P310

Smiths Medical Announces Correction for paraPAC Plus P300 and P310 Ventilators Due to Unintentional Tidal Volume Knob Movement
 
This recall is aimed at rectifying device issues, and it does not involve the removal of products from their operational locations or sales outlets. The FDA has classified this recall as a serious one. Continuing to use this device without corrections may result in serious injury or death.

Products Affected

paraPAC Plus Ventilator
  • Product Names: paraPAC Plus P300 ventilator and paraPAC Plus P310 ventilator
  • Lot/Serial Numbers: All lots and serial numbers

Recommended Actions

  • Examine all paraPAC Plus P300 and P310 ventilators to find if they are affected.
    • Turn the tidal volume knob to its lowest setting to check if it remains in place.
    • Turn the tidal volume knob to its highest setting and see if it stays set.
  • If the knob shifts or alters its position from the set point, cease use of the product until repairs are made.
  • Do not attempt to fix the issue on your own.

On May 31, 2024, Smiths Medical issued an Urgent Medical Device Correction letter to all affected customers with the following recommendations:

  • Identify all affected serial numbers for paraPAC Plus.
  • Conduct inspections as follows:
    • Rotate the tidal volume knob to the lowest position to see if it remains set or moves.
    • Turn the knob to the highest position to verify if it stays put.
  • If the knob remains secure, the product is unaffected.
    • Continue normal usage of the device.
    • Fill out the response form to confirm non-affected status.
  • If the knob shifts, the product is affected.
    • Take it out of service until it can be repaired.
    • Do not use or repair the affected product.
    • Notify Global Complaint Management at globalcomplaints@icumed.com.
    • Complete the response form indicating how many products are affected.
  • Distribute this recall notice to all potential device users for awareness of the recall and suggested actions.
  • Submit the Customer Response Form to smithsmedical3920@sedgwick.com within ten days to confirm receipt.
  • Distributors should relay this notice to any customers who may possess affected products.

Reason for the Correction

The recall by Smiths Medical addresses the risk of the tidal volume knob inadvertently moving on paraPAC Plus P300 and P310 ventilators. The knob may unexpectedly shift when set at high (1000 – 1500 ml) or low (70 – 150 ml) levels. Such movement could delay therapy or result in excessive or insufficient tidal volume for the patient.

Using affected devices may lead to severe health risks such as barotrauma, hyperventilation, hypoventilation, hypercarbia, acidosis, hypoxia, bradycardia, hypotension, cardiopulmonary arrest, and even death.
  
No injuries or fatalities related to this issue have been reported.

Usage of the Device

Smiths Medical’s PneuPAC paraPAC Plus P300 and P310 Ventilators are gas-powered, portable ventilators designed for emergencies and transport in vehicles like airplanes and helicopters. They are suitable for use during emergencies at accident sites and for patient transport between medical facilities. The devices provide respiratory support for patients of varying ages above approximately 10 kg.

They are also capable of delivering free flow oxygen therapy and CPAP for patients who are breathing spontaneously. Furthermore, they can be utilized for CPR resuscitation during emergencies.

ParaPAC Plus ventilators should only be operated under the close supervision of trained healthcare professionals.

Contact Information

U.S. customers with inquiries regarding this recall can reach out to Smiths Medical Technical Support at 1-800-241-4002, option 3.

Additional FDA Resources

Unique Device Identifier (UDI)

The Unique Device Identifier (UDI) assists in identifying individual medical devices sold in the U.S. from manufacturing through distribution and patient use. It allows for enhanced accuracy in reporting and reviewing adverse events, facilitating quicker identification of issues and corrections.

How to Report a Problem

Healthcare professionals and consumers are encouraged to report adverse reactions or quality issues they encounter while using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.