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  5. Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector
  1. Medical Device Recalls

Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

PneuPAC paraPAC Plus Ventilator
  • Product Names: PneuPAC paraPAC Plus P300 and P310 Ventilators
  • Unique Device Identifier (UDI)/List Number: /P300NXX*, / P310NXX*
  • Model Numbers: All models are affected.

What to Do

  • Inspect the patient outlet connector on all paraPAC plus ventilators.
  • Remove any paraPAC plus ventilator from use if the patient outlet connector is loose or moves.

On May 31, 2024, Smiths Medical sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

  • Inspect all potentially affected paraPAC plus units to determine if devices are affected:
    • Perform a visual inspection to determine if the outlet connector is disconnected.
    • Evaluate the connector physically to determine if the outlet connector is loose or moves when placing a patient circuit on the connector or when removing it.
  • Remove any device where the outlet connector moves or feels loose so it can be repaired by Smiths Medical.
  • Report removed devices to Global Complaint Management at globalcomplaints@icumed.com.
  • Continue to use devices if the outlet connector remains tight after physical inspection, maintaining heightened awareness and following all pre-use checks as per the user manual.
  • Pre-checks must be completed as described in the user manual for every use after inspection.
    • Take extra caution to inspect the outlet connector prior to each use, before placing the patient circuit on the connector, and during removal.
  • Be sure to follow all instructions including warnings and cautions in the UserManual Doc. numbers (10018833-003 and/or 10026347-002) when using these devices, including:
    • All pre-use checks must be performed before each use.
    • Constant patient monitoring.
    • Monitor blood oxygenation and end tidal carbon dioxide levels independently with pulse oximetry and capnography.
    • Have alternate means of ventilation, such as bag mask ventilation, available in case of ventilator failure or malfunction.
  • The following design mitigation and alarms may be triggered by this issue:
    • Low Pressure/Disconnect alarm
    • Pressure Monitor: Disconnection/detachment of the patient outlet connector would be indicated by no movement of the manometer needle.
  • Share this recall notification with all potential users of the devices to ensure they are aware of the issue and proposed mitigations.
  • Complete and return the customer response form included with the letter to smithsmedical5253@sedgwick.com within 10 days of receipt.
  • DISTRIBUTORS: Immediately forward this notice to any customer who may have received these devices from you. Request that they complete the response form and return it to smithsmedical5253@sedgwick.com.

Reason for Recall

Smiths Medical is recalling paraPAC plus P300 and P310 ventilators due to the possibility that the patient outlet connector may loosen or detach, which will impact active ventilation. If the patient outlet connector is loosened or detached it could cause extended interruption of therapy, no ventilation, delay of therapy and reduced tidal volume.

The use of affected product may cause serious adverse health consequences, including not enough ventilation (hypoventilation), not enough oxygen (hypoxia), slowed heart beat (bradycardia), low blood pressure (hypotension), a sudden stop of the lungs (respiratory arrest), and death.

There has been one reported injury. There has been one report of death.

Device Use

Smiths Medical PneuPAC paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators, including in vehicles such as airplanes and helicopters. They are suitable for emergency use at an accident scenes and transports between hospitals or within a hospital or medical facility. These ventilators are intended to provide ventilatory support for adults, children, and infants (above approx. 10 kg).

The paraPAC Plus devices also provide free flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients. The devices can also be used in emergency situations to provide ventilatory support for CPR resuscitation.

ParaPAC Plus ventilators should only be used under the constant supervision of trained health care professionals.

Contact Information

Customers in the U.S. with questions about this recall should contact Smiths Medical Technical Support at 1-800-241-4002, option 3.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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