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.
- Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)
- Serial Numbers: All serial numbers below 16192 with software versions ≤ 2.60
- Manufacturing Dates: November 29, 2007 – October 31, 2018
- Distribution Dates: November 29, 2007 – October 31, 2018
- Devices Recalled in the U.S.: 4338 Units
- Date Initiated by Firm: February 11, 2019
The Hamilton-G5 is intended for use by health care providers to provide breathing support for adult, pediatric, infant and neonatal patients. This device is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate transport within a hospital or hospital type facility.
Reason for Recall
Hamilton Medical AG is recalling Hamilton-G5 Ventilators due to the potential for “Panel connection lost” error message resulting in the ventilator to stop working and enter an ambient state. When the ventilator enters an ambient state, the patient breathes room air unassisted and the ventilator sounds a high priority alarm with visual blinking LEDs alerting medical staff. When the ventilator enters the ambient state, alternative ventilation must be provided immediately. Hamilton Medical AG has received 14 complaints associated with the error message, however no patient injury or death have been reported due to the issue.
Hamilton Medical AG had developed a new software for the Hamilton-G5 ventilators. The software version 2.80 reduces the likelihood of the ventilator entering an ambient state due to the occurrence of an error leading to a “panel connection lost” error message.
Use of the affected device, without the new software, may lead to risk of immediate or long-term consequences to a patient that may result in irreversible harm, injury, or death.
Who May be Affected
- Health care providers, distributers, and facilities using Hamilton-G5 Ventilators.
- Patients who receive breathing support using a Hamilton-G5 Ventilator.
What to Do
On February 11, 2019, Hamilton Medical AG sent customers a “Medical Device Field Safety Corrective Action” notice informing customers of the affected model and serial numbers.
The notice provided the following information:
Actions required by device operators:
In the event of the error occurring, the HAMILTON-G5/S1 ventilator ceases ventilation and enters an ambient state take the following action:
- Check and monitor your patient for safety.
- Provide alternative ventilation immediately.
- Turn off the affected HAMILTON-G5/S1 ventilator.
- Contact your distributor and have the affected HAMILTON-G5/S1 ventilator updated with software version 2.80.
Please keep this information with your HAMILTON-G5/S1 ventilators instructions for use.
Actions required by the distributors:
Distribute this Medical Device Safety Alert immediately to all operators of the HAMILTON-G5/S1 ventilators and take the following action:
- Update the HAMILTON-G5/S1 ventilator units with software version 2.80.
- Update the HAMILTON-G5/S1 Operator’s Manual for software version 2.80 as soon as possible upon its availability.
- Update progress of field safety corrective action in the ky2help database.
Actions by the manufacturer:
- Inform all partners of the availability of the HAMILTON-G5/S1 software version 2.80.
- Provide new software version 2.80 to all distributors
- Provide updated HAMILTON-G5/S1 Operator’s Manual for software version 2.80.
If you are aware of any incidents related to this issue or if you have any questions, please contact Hamilton Medical Inc. immediately at 1-800-426-6331, option #2, and/or e-mail: email@example.com, to provide information regarding those events so regulatory reporting obligations can be fulfilled.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.