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  5. Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement
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Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement 
 
This recall involves correcting devices, and does not involve removing them 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 without correction.  

Affected Product (Include the following information)

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

What to Do  

  • Inspect all paraPAC Plus P300 and P310 ventilators to determine if devices are affected.
    • Rotate tidal volume knob to lowest position to see if it stays in position.
    • Rotate tidal volume knob to highest position to see if it stays in position.
  • If the knob moves or changes position from where it was set, the product should be removed from use until it can be repaired. 
  • Do not independently attempt to repair this issue. 

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

  • Identify all affected paraPac plus serial numbers.
  • Perform an inspection to determine if devices are affected by: 
    • Rotating the tidal volume knob to the lowest position of the control to see if it stays in the set position or if it moves.
    • Rotate tidal volume knob to the highest position of the control to see if it stays in the set position or if it moves.
  • If the knob stays in the set position when tested, then your product is not affected.
    • Continue to use the device as normal. 
    • Complete the response form to confirm there is no affected product. 
  • If the knob moves or changes position from the set position, then your product is affected.
    • Remove it from use until it can be repaired.
    • Do not attempt to use or repair the affected product. 
    • Report the event to Global Complaint Management at globalcomplaints@icumed.com.
    • Complete the response form identifying the number of affected products.
  • Share the recall notification with all potential users of the devices to ensure they are aware of this recall and proposed mitigations.
  • Return the attached Customer Response Form as noted above to smithsmedical3920@sedgwick.com within ten days of receipt to acknowledge understanding.
  • Distributors should immediately forward this notice to any customers who may have received affected product. 

Reason for Correction  

Smiths Medical is correcting paraPAC Plus P300 and P310 ventilator due to a risk of inadvertent movement of the device’s tidal volume knob. When the knob is set at high (1000 - 1500 ml) or low (70 - 150 ml), the knob may move away from the original setting on its own. If the tidal volume knob moves, it may cause the patient to experience delayed therapy, too much tidal volume or not enough tidal volume. 

The use of affected product may cause serious adverse health consequences, including injury from air pressure (barotrauma), too much ventilation (hyperventilation), not enough ventilation (hypoventilation), a build up of carbon dioxide (hypercarbia) or acid (acidosis) in the body,  not enough oxygen (hypoxia), slowed heart beat (bradycardia), low blood pressure (hypotension), a sudden stop of the heart and lungs (cardiorespiratory arrest), and death.  
  
There have been no reported injuries and no reports 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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