Hamilton Medical Inc is recalling the Hamilton-C1, T1, and 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.” 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, according to a recall notice on the US Food and Drug Administration’s (FDA) website.
The FDA has identified this as a Class I recall, the most serious type of recall.
- 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 Aug 8, 2020
- Devices recalled in the US: 1,468
- Date initiated by firm: July 26
On July 26, Hamilton Medical 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 at 1-800-426-6331 or email [email protected].