The FDA recently warned the public about a correction issued by Smiths Medical for its paraPAC Plus P300 and P310 Ventilators. The company requests that health care facilities follow all of the steps outlined in the correction recall to prevent injury and death while using the paraPAC Plus P300 and P310 Ventilators.
Smiths Medical announced the correction on May 31, 2024, after noticing a potential malfunction with the tidal volume knobs on the affected models. In some instances, when positioned at the highest or lowest setting, the tidal knob turns up or down on its own, which effectively changes the air flow delivered to the patient. As a result, health care providers can not reliably predict the rate of air flow delivery to patients when using ventilators with this particular defect.
To address the situation, Smiths Medical notified all users, asking them to inspect their paraPAC Plus P300 and P310 Ventilators closely. The proposed inspection steps are as follows:
- Check for movement after placing the tidal volume knob at its highest setting.
- Check for movement after placing the tidal volume knob at its lowest setting.
If the knob drifts in either of these scenarios, Smiths Medical advises providers to cease use of the ventilators and to contact globalcomplaints@icumed.com for instructions on having the products repaired. Customers can continue using the ventilators if during testing, the tidal volume knob remains set in the chosen position and does not drift. In either event, all users should complete the Customer Response Form provided by the company and send it to smithsmedical3920@sedgwick.com.
The paraPAC Plus P300 and P310 Ventilators are designed to provide emergency ventilation support to adults and children over 22 pounds. The devices are typically used while transporting patients via air or ground ambulance but may also be used in a hospital setting. While no injuries have been reported thus far as a result of these products, unintended movement of the tidal wave knob could have serious consequences for the patient. These consequences might include hyper- or hypoventilation, a build up of carbon dioxide, acidosis, hypoxia, decreased heart rate, hypotension, and in extreme cases, malfunction of the heart and lungs, and death.
Customers with questions or concerns about the recall can contact Smiths Medical Technical Support at 1-800-241-4002, option 3.
Patients and health care providers can report any new adverse health events related to the paraPAC Plus P300 and P310 Ventilators through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an adverse health outcome, after receiving ventilation with a paraPAC Plus P300 or P310 Ventilator, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to health care facilities in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.