Chicago
Case Types We Handle
Personal Injuries
Car Accidents
Truck Accidents
Motorcycle Accidents
Bicycle Accidents
Construction Accidents
Nursing Home Abuse
Wrongful Death
Slip and Fall Accidents
Daycare Injury & Abuse
Edwardsville
Case Types We Handle
Personal Injuries
Car Accidents
Truck Accidents
Motorcycle Accidents
Bicycle Accidents
Nursing Home Abuse
Wrongful Death
Slip and Fall Accidents
Daycare Injury & Abuse
Premises Liability
St. Louis
Case Types We Handle
Personal Injuries
Car Accidents
Truck Accidents
Motorcycle Accidents
Bicycle Accidents
Construction Accidents
Nursing Home Abuse
Wrongful Death
Slip and Fall Accidents
Daycare Injury & Abuse
Dangerous Drugs
Defective Products
Chemical Exposure

Smiths Medical Ventilator Lawsuit [December 2024 Update]

Smiths Medical Ventilators Potentially Linked to Serious Injury

The Smiths Medical ventilator lawsuit investigation centers on allegations that manufacturing defects and inadequate quality controls in the paraPAC Plus P300 and P310 ventilators led to serious injuries and fatalities, placing patients at risk due to device malfunctions that disrupted life-sustaining respiratory support.

Our lawyers are actively investigating potential personal injury or product liability claims related to these devices.

On this page, we’ll discuss the potential Smiths Medical ventilator lawsuit, the Smiths Medical recall for certain ventilator devices, how these devices work and where they are used, and much more.

Smiths Medical Ventilator Lawsuit; Smiths Medical Ventilator Recall Lawsuit

Legal Investigation: Injuries Related to Smiths Medical Ventilator

Smiths Medical, now part of ICU Medical, has recently issued several recalls for its ventilators due to safety concerns.

These recalls have been classified as Class I by the U.S. Food and Drug Administration (FDA), indicating a potential for serious injury or death.

The primary models involved in these recalls are the paraPAC Plus P300 and P310 ventilators.

These devices are designed to provide respiratory support to patients in various healthcare settings.

The recall concerning the loose patient outlet connector has been associated with reports of injuries and at least one death.

The other recalls, including those related to the tidal volume knob movement and continuous positive gas flow malfunction, have not reported any injuries or deaths.

Smiths Medical has faced multiple quality issues in recent years.

In 2021, the company received a warning letter from the FDA, and in 2024 alone, there have been seven Class I recalls involving the company.

Lawyers are investigating claims from individuals who have been injured and also from family members of those who have tragically passed away potentially due to the defects in these devices.

If you or a loved one suffered injuries related to the recalled Smiths Medical Ventilators, you may be eligible to file a lawsuit and seek compensation.

Our lawyers are actively investigating the Smiths Medical recall and are speaking to potential clients about their situations.

Reach out to us today for a free consultation.

Table of Contents

About the Smiths Medical Ventilator Recall

The Smiths Medical ventilator recall relates to serious risks associated with device malfunctions in critical care settings.

Multiple recalls have been issued for the paraPAC Plus P300 and P310 ventilators, primarily due to design and manufacturing defects.

Smiths Medical’s gas-powered portable ventilators, used to deliver oxygen therapy and ventilation at accident scenes and during transport, have been linked to significant malfunctions.

These include a loose or detached patient outlet connector, inadvertent movement of the tidal volume knob, and issues with continuous positive gas flow, all of which compromise the device’s ability to deliver proper respiratory support.

These devices are critical in emergency settings, including use in airplanes and helicopters, providing continuous positive airway pressure (CPAP) and ventilatory support during CPR resuscitation.

However, the FDA reported that the ventilators may intermittently provide continuous positive gas flow instead of cycling like a human breath when set to “ventilate” mode.

This malfunction can result in inadequate oxygen delivery (hypoventilation), airway obstruction, and potentially life-threatening consequences, including serious injury or death.

The FDA has classified these recalls as Class I, indicating the highest level of risk, with the potential for severe injury or death.

Despite the recall, the company advised continued use of the devices with heightened monitoring, urging users to check patient oxygenation and carbon dioxide levels and have backup ventilation equipment available.

If continuous flow issues arise, the ventilators should be removed from clinical use and set aside for repair.

Defects in Smiths Medical Ventilators and Their Risks

The recalls of Smiths Medical paraPAC Plus P300 and P310 ventilators stem from multiple serious defects, each posing unique risks to patient safety.

These malfunctions undermine the device’s ability to provide effective ventilation, exposing patients to potential injury or death.

Loose or Detached Patient Outlet Connector

  • Defect Description: The patient outlet connector can loosen or detach during use, resulting in a sudden disconnection of the breathing circuit.
  • Risks:
    • Interruptions in ventilation, causing hypoxia or respiratory failure.
    • Increased reliance on manual ventilation, requiring immediate intervention by medical staff.
    • Delayed emergency response due to unanticipated equipment failure.
  • Reported Incidents:
    • One injury and one death attributed to this defect.

Inadvertent Movement of the Tidal Volume Knob

  • Defect Description: The tidal volume adjustment knob may inadvertently shift, altering ventilation settings without user input.
  • Risks:
    • Inadequate ventilation volumes, leading to insufficient oxygen delivery.
    • Excessive ventilation, potentially causing barotrauma or other respiratory complications.
    • Difficulties in maintaining consistent treatment parameters, especially in critical care settings.
  • Clinical Implications:
    • Increased monitoring demands on healthcare staff to identify and correct changes promptly.
    • Greater risk of adverse events in high-acuity patients.

Continuous Positive Gas Flow Malfunction

  • Defect Description: The ventilator may intermittently provide continuous positive gas flow instead of intended cycling, mimicking a human breath.
  • Risks:
    • Ineffective ventilation, resulting in poor oxygenation and carbon dioxide retention.
    • Risk of hyperinflation of the lungs or airway pressure imbalances.
    • Potential damage to lung tissue over prolonged periods of malfunction.
  • Operational Concerns:
    • Complications in identifying the defect during active use.
    • Challenges in troubleshooting and resolving the issue without alternative equipment on hand.

Other Reported Issues

  • Recurring Quality Concerns: Smiths Medical has faced ongoing scrutiny for its manufacturing practices, including multiple Class I recalls and prior FDA warnings.
  • Impact on Healthcare Providers:
    • Additional strain on medical staff to mitigate risks associated with defective equipment.
    • Increased dependency on backup ventilation devices during recalls.

Healthcare providers are urged to review the recall notices thoroughly and adhere to the manufacturer’s guidance for repairs or replacements.

Vigilant monitoring of patients using these devices is critical to prevent further adverse events.

What are the Smiths Medical Ventilators Used For and How?

Smiths Medical ventilators, including the paraPAC Plus P300 and P310 models, play a critical role in providing respiratory support to patients who are unable to breathe adequately on their own.

These devices are essential in emergency medical services, intensive care units, and other healthcare settings, where precise and reliable ventilation is crucial for patient survival.

These medical devices are often used in:

  • Emergency Medical Services (EMS):
    • Designed for portability, these ventilators are frequently used by EMS teams during pre-hospital care.
    • They provide immediate respiratory support to stabilize patients in critical conditions, such as respiratory failure, cardiac arrest, or trauma.
  • Hospital Settings:
    • Used in operating rooms to maintain patient ventilation during surgery under general anesthesia.
    • Common in intensive care units (ICUs) for patients requiring long-term respiratory support due to illnesses such as pneumonia, COPD, or severe COVID-19.
  • Transport Scenarios:
    • Ideal for use in air or ground medical transport, where compact, durable equipment is needed.
    • Ensures uninterrupted ventilation for patients being transferred between facilities.

How the paraPAC Plus Ventilators Work

The paraPAC Plus ventilators are designed to deliver precise and customizable respiratory support to patients in need.

These devices are portable and adaptable, making them suitable for use in emergency, hospital, and transport settings.

Their functionality ensures proper oxygenation and ventilation, mimicking natural breathing patterns.

  • Modes of Ventilation:
    • Provides manual, assist-control, and continuous positive airway pressure (CPAP) options.
    • Enables healthcare providers to tailor respiratory support to each patient’s condition.
  • Customizable Settings:
    • Adjustable tidal volume and oxygen concentration ensure patients receive appropriate airflow.
    • Designed to meet the needs of diverse patient populations, from pediatric to adult.
  • Key Features:
    • Lightweight and battery-powered for ease of transport and portability.
    • Integrated alarms signal issues such as disconnections or low oxygen levels, aiding in rapid intervention.
  • Delivery Mechanism:
    • Supplies pressurized air or oxygen directly to the lungs via endotracheal tubes, masks, or other airway devices.
    • Ensures continuous removal of carbon dioxide while maintaining oxygen saturation.

These features make paraPAC Plus ventilators extremely useful in critical care, especially when immediate, reliable respiratory support is required.

How Might Injuries or Deaths Occur in Relation to Smiths Medical Ventilator Defects?

Injuries or deaths related to Smiths Medical ventilator defects occur when critical malfunctions prevent the device from delivering adequate respiratory support.

A loose or detached patient outlet connector can interrupt ventilation entirely, leading to hypoxia or respiratory failure if not addressed immediately.

Malfunctioning tidal volume knobs may alter airflow settings, causing patients to receive insufficient or excessive ventilation, potentially resulting in respiratory distress or lung damage.

Continuous positive gas flow issues can create imbalances in airway pressure, increasing the risk of hyperinflation or tissue injury.

These defects often require urgent intervention by healthcare providers, who may not have immediate backup equipment available.

Delays in identifying or resolving these issues can exacerbate complications, especially for critically ill or ventilator-dependent patients.

Such failures, particularly in emergency or transport scenarios, heighten the risk of fatal outcomes.

TorHoerman Law: Investigating Injuries & Deaths Linked to Smiths Medical Ventilator Devices

The recall of Smiths Medical paraPAC Plus P300 and P310 ventilators has raised significant concerns about patient safety and device reliability.

These ventilators, used in critical care and emergency settings, have been linked to serious malfunctions, including ventilation interruptions and improper airflow delivery.

Reports of injuries and death have prompted lawyers to investigate potential claims on behalf of affected patients and their families.

Legal investigations aim to determine whether manufacturing defects, inadequate quality controls, or failure to warn contributed to the harm caused by these devices.

Patients who suffered injuries or lost loved ones due to these defects may have legal options to pursue compensation for medical expenses, emotional distress, and other damages.

Contact us for a free consultation.

Frequently Asked Questions

  • What Smiths Medical Ventilator Devices are Recalled?

    Smiths Medical has issued recalls for specific ventilator models due to safety concerns.

    The primary devices affected are the paraPAC Plus P300 and P310 ventilators.

    These recalls address issues such as loose or detached patient outlet connectors, unintended movement of the tidal volume knob, and continuous positive gas flow malfunctions.

    Healthcare providers using these models should consult the manufacturer’s recall notices for detailed information and guidance.

    Recalled devices:

    • paraPAC Plus P300 Ventilator
    • paraPAC Plus P310 Ventilator

  • In What Settings are These Ventilator Devices Used?

    Smiths Medical ventilators, including the recalled paraPAC Plus P300 and P310 models, are used in various critical care and emergency settings.

    These devices provide essential respiratory support in environments where patients are unable to breathe or gather enough oxygen independently.

    Their portability and versatility make them suitable for use during transport, in hospitals, and by emergency medical services (EMS).

    The ventilators are also commonly employed in operating rooms and intensive care units (ICUs) to support patients with respiratory distress or undergoing surgery.

    Settings where ventilator devices are used:

    • Emergency Medical Services (EMS): For pre-hospital care and stabilization during transport.
    • Hospitals: Including operating rooms for anesthesia and ICUs for long-term respiratory support.
    • Transport Scenarios: Air or ground medical transport requiring continuous ventilation.
    • Critical Care Environments: Managing severe respiratory illnesses like pneumonia or COPD.
    • Trauma Care: Providing immediate respiratory assistance in life-threatening situations.

  • Who Can File a Lawsuit Related to the Smiths Medical Ventilator Recall?

    Individuals who were injured by the malfunction of a recalled Smiths Medical ventilator may be eligible to file a lawsuit.

    This includes patients who experienced complications such as respiratory failure, hypoxia, or lung damage due to the device’s defects.

    Families of patients who suffered fatal outcomes linked to these malfunctions may also pursue wrongful death claims.

    Additionally, healthcare providers who faced challenges or liabilities because of the defective ventilators may have grounds for legal action.

    An experienced lawyer can help determine eligibility and explain the legal process for those impacted by the recall.

    It is critical to act quickly, as legal claims may be subject to specific statutes of limitations.

Published By:
Tor Hoerman

Tor Hoerman

Owner & Attorney - TorHoerman Law

Do You
Have A Case?

Here, at TorHoerman Law, we’re committed to helping victims get the justice they deserve.

Since 2009, we have successfully collected over $4 Billion in verdicts and settlements on behalf of injured individuals.

Would you like our help?

About TorHoerman Law

At TorHoerman Law, we believe that if we continue to focus on the people that we represent, and continue to be true to the people that we are – justice will always be served.

Do you believe you’re entitled to compensation?

Use our Instant Case Evaluator to find out in as little as 60 seconds!

$495 Million
Baby Formula NEC Lawsuit

In this case, we obtained a verdict of $495 Million for our client’s child who was diagnosed with Necrotizing Enterocolitis after consuming baby formula manufactured by Abbott Laboratories.

$20 Million
Toxic Tort Injury

In this case, we were able to successfully recover $20 Million for our client after they suffered a Toxic Tort Injury due to chemical exposure.

$103.8 Million
COX-2 Inhibitors Injury

In this case, we were able to successfully recover $103.8 Million for our client after they suffered a COX-2 Inhibitors Injury.

$4 Million
Traumatic Brain Injury

In this case, we were able to successfully recover $4 Million for our client after they suffered a Traumatic Brain Injury while at daycare.

$2.8 Million
Defective Heart Device

In this case, we were able to successfully recover $2.8 Million for our client after they suffered an injury due to a Defective Heart Device.

Guides & Resources
Do You
Have A Case?

Here, at TorHoerman Law, we’re committed to helping victims get the justice they deserve.

Since 2009, we have successfully collected over $4 Billion in verdicts and settlements on behalf of injured individuals.

Would you like our help?

You can learn more about the Smiths Medical Ventilator by visiting any of our pages listed below:

All
FAQs
Injuries & Conditions
Legal Help
Settlements & Compensation
Other Resources

Share

Related Posts

What Our Clients Have To Say