This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Name: HAMILTON-C6
- Unique Device Identifier (UDI)/Product Number: 07630002808590/160021
- Product Software Versions
- v1.1.4
- v1.1.5
- v1.1.6
What to Do
For Users
If the HAMILTON-C6 Medical Ventilator enters sensor fail mode during open suction procedures but never re-starts ventilation after the patient is reconnected to the ventilator, the company recommends one of four ways to re-start it:
- Select and confirm a control setting (even without a change of the value)
- Select and confirm a new ventilation mode
- Switch the ventilator to standby mode and restart ventilation from standby mode
- Switch the ventilator off and switch it on again
Ventilate the patient by alternative means if unable to manually re-initiate ventilation through one of the ways described above.
On May 6, 2024, Hamilton Medical sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
- Check the software version of HAMILTON-C6 devices in the facility.
- Ensure medical staff is aware of the letter’s content.
- Attach the letter to each affected device's operator's manual to ensure quick access.
- Contact the facility’s local distribution partner if a software update is required. They will support the update of affected devices with high priority.
- Read and sign the confirmation sheet on the last page of the letter.
- Forward the notice to distribution partners within 28 calendar days of receipt.
The affected devices should be updated to the newest available software version 1.2.3 without undue delay. The software update contains the required fix.
Reason for Correction
Hamilton Medical is correcting software for the HAMILTON-C6 Medical Ventilator because the ventilator may fail to restart ventilation if it enters sensor fail mode after open suction is performed and the patient is reconnected. The ventilator may not re-start ventilation if the ventilator is using software versions 1.1.4, 1.1.5, and 1.1.6, and:
- The user presses the hard key “O2 enrichment” and disconnects the endotracheal tube from the ventilator circuit for open suctioning.
- A sensor error takes place due to an issue such as kinked flow sensor tubing.
- The ventilator switches to sensor fail mode.
- The patient is re-connected to the ventilator while sensor fail mode is still active.
The use of affected products may cause serious adverse health consequences, especially for the most vulnerable patients, including slow, shallow (hypoventilation), or stopped (apnea) breathing, low blood oxygen (hypoxemia), slow heart rate (bradycardia), build-up of carbon dioxide (hypercarbia), a rise in pressure inside the skull (increased intracranial pressure), and death.
There has been one reported injury and one report of death.
Device Use
The HAMILTON-C6 Medical Ventilator is intended to provide mechanical ventilation or breathing support for children (pediatric) and adult patients. It may also be used for infants (neonates). It is used in hospital and health care settings including intensive care, emergency, long term acute care, and the recovery room. It is also used to transfer ventilated patients within the hospital.
The HAMILTON-C6 Medical Ventilator is used by qualified, trained healthcare professionals under the direction of a doctor.
Contact Information
Customers in the United States with questions about this recall should contact their local distribution partner or Hamilton Medical AG Technical Support by email at techsupport@hamilton-medical.com.
Additional FDA Resources
Additional Company Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
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.
