Developers: | Hamilton Medical |
Branches: | Pharmaceuticals, Medicine, Healthcare |
2022: Recall of a number of devices due to a hardware problem
In late June 2022, Hamilton Medical issued a safety notice warning of problems with some ventilators. We are talking about a line of Hamilton-C6.
An analysis of specialists from Hamilton Medical on customer complaints revealed a hardware problem related to the status indicator board on artificial ventilation devices (IVL) of the Hamilton-C6. The board can weaken, which can lead to broken contact with the main board and potential oxidation of the contact due to water entering it.
A faulty contact causes a technical fault to be detected within a very short time, causing log entries to overflow, causing the fan to switch to safe ventilation or a ventilator to the environment with the device losing communication with the panel.
According to the warning dated June 10, 2022, according to the results of the risk assessment conducted by Hamilton Medical, this problem is almost impossible, however, for a passive patient, the state of ventilation of the environment can lead to a serious deterioration in his health. In the event of such a situation, the ventilator displays a high level alarm (audible and visible) to make the defect easily detectable.
The warning was sent to all medical facilities using Hamilton-C6 ventilators, including intensive care units, intermediate care units, emergency departments, long-term urgent care hospitals and recovery treatment units. In addition, the addressees include all distributors of Hamilton-C6 devices and their service engineers.
The company told users of its devices that if the status indicator board is disconnected, the front housing containing the status indicator board should be replaced immediately. The replacement prevents the ingress of water, which can bring the devices into a potentially problematic state. The notice from Hamilton Medical also says the service engineer will contact affected customers soon. Users are also urged to ensure constant access to alternative ventilation facilities.[1]