Hamilton Ventilator Recall Issued Over Short Circuit, Capacitor Leak Risks

The FDA warns that the recalled Hamilton ventilators may fail and stop providing potentially life-saving air therapy support to patients due to design problem.

More than 1,000 Hamilton ventilators are being recalled, due to a risk that the devices may suddenly short circuit and fail, which could put patients at risk of severe injury and death.

The U.S. Food and Drug Administration (FDA) announced the Hamilton ventilator recall on October 18, indicating the capacitors may leak electrolyte fluid onto the device’s control board, which can result in a sudden short circuit event and cause unexpected loss of breathing assistance to patients.

Healthcare professionals use the mechanical ventilators to provide breathing support to newborns, infants, children, and adult patients while they are transported in and out of a hospital setting. While no injuries have been reported in relation to the recalled ventilators, the interrupted or complete lack of air therapy treatment may lead to serious and potentially fatal injuries.

Hamilton Ventilator Short Circuit Recall

The FDA has given the Hamilton ventilator recall a Class I designation, warning medical professionals that patients face an increased risk of sustaining severe injuries or dying if they continue using the devices.

According to the recall, leaking ventilator capacitors can short circuit the control board, which can switch the device into an “Ambient State,” causing the ventilator to suddenly stop working and fail.

In the event of a ventilator failure, patients will require immediate action from a medical professional and need an alternative device, or may require a manual resuscitation device to supply them with air.

The recall impacts approximately 1,468 Hamilton ventilators distributed from July 28, 2020 until August 8, 2020 and includes the following models:

• Hamilton-C1, Portable Intensive Care Ventilator, REF: 161001
• Hamilton-T1, Intensive Care and Transport Ventilator, REF: 161006
• Hamilton-T1, Intensive Care and Transport Ventilator, REF: 161009
• Hamilton-MR1, Intensive Care Ventilator, REF: 161010
• Hamilton C1, T1, and MR1 models, Control Board Spare Part, REF: MSP161502/12
• Hamilton-T1, ESM Shielding Set Spare Part, REF: MSP161339/02

Hamilton issued an urgent medical device correction letter to healthcare professionals on July 23, requesting them to provide patients with an alternative ventilation method. The letter also provided instructions on how to exit the device’s “Ambient State,” and service the ventilator.

The ventilators can be returned to patient use after they are serviced and pass the software test requirements. For more information on the recall, consumers may contact Hamilton Medical Inc. by phone at 1-800-426-6331, or email reno.techsupport@hamiltonmedical.com.

Consumers are urged to report any problems they experienced after using the recalled ventilators to the MedWatch Adverse Event Reporting program.