July 15, 2024
At a Glance
- A ventilator software problem has been linked to one reported death and one reported injury.
Hamilton Medical is correcting software for its Hamilton-C6 ventilator after one reported injury and one report of death.
According to FDA, the company found that the device 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.
Your software testing game has got to be on point here, including usability and cases that can pop up in clinic.
The company recommends one of four ways to restart the Hamilton-C6 ventilator if it enters sensor fail mode during open suction procedures but never restarts ventilation after the patient is reconnected to the machine:
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, the company notes.
A recent LinkedIn post from the risk management and quality engineering community raises an important point about this particular device correction and the importance of software testing.
"Were I on the remediation team for this one, I'd look to see if there was a test for this situation and related ones and get them written and conducted if not. If they were written, I'd want to know what they missed and work with the team to tighten them up," wrote Rafael Pozos, a senior risk management practitioner and quality engineer. "Your software testing game has got to be on point here, including usability and cases that can pop up in clinic."
About the Author
You May Also Like