The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: Hamilton C1/T1/MR-1 Ventilators
- Product Codes: See Recall Database Entry
- Model Numbers:
- Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
- Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
- Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
- Hamilton-MR1, REF: 161010, Intensive Care Ventilator
- Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part
- Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part
- Distribution Dates: July 28, 2020 to August 8, 2020
- Devices Recalled in the U.S.: 1,468
- Date Initiated by Firm: July 26, 2023
Hamilton ventilators are used to support adults, children, infants and newborns with breathing. Health care professionals use them during patient transport in or outside hospital settings.
Reason for Recall
Hamilton Medical, Inc. is recalling the HAMILTON-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventilator’s control board. If the control board contacts the electrolyte fluid, the control board or installed spare parts could short circuit. As a result of the short circuit, the ventilator may switch to “Ambient State.”
During the ‘Ambient State’ the ventilator will alarm and display the following on the screen:
A “Realtime clock failure” may also appear on the screen and the user will be notified to set a date and time:
The ‘Realtime clock failure’ will not have severe effects, but the ‘Ambient State’ failure will require immediate action. ‘Ambient State’ may require a health care professional to provide air supply to the patient with a manual resuscitating device and use another ventilator. Serious injury or death may result for patients who do not breathe on their own or do not receive immediate intervention.
There have been zero reported incidents, injuries, or deaths related to this recall.
Who May be Affected
- People who receive breathing support from HAMILTON-C1, T1, MR-1 ventilators.
- Health care providers who provide breathing support care for patients with HAMILTON-C1, T1, MR-1 ventilators.
What to Do
On July 26, 2023, Hamilton Medical Inc. sent all affected customers an Urgent Medical Device Correction letter. The letter requested customers to:
• Provide alternative ventilation immediately if the ‘Ambient State’ screen appears.
• Switch off ventilator power to exit the 'Ambient State.'
• Ensure patient safety and then service the ventilator.
This recall is considered a correction because the device can be returned to use after passing the service software tests.
Customers with questions about this recall should contact Hamilton Medical Inc. at 1-800-426-6331 or email firstname.lastname@example.org.
Full List of Affected Devices
A complete list of affected devices is available in the Medical Device Recalls database.
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 using an online form, regular mail, or FAX.