| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00707-1 |
| Product Name/Description |
HAMILTON-C1/T1/MR1 Ventilators
Product codes: HMT-161006, HMT-161001, HMT-161010
118x specifically identified serial numbers
ARTG 187874
(Device Technologies Australia Pty Ltd - Ventilator, transportable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/08/2023 |
| Responsible Entity |
|
| Reason/Issue |
A degrading capacitor on specifically identified control boards might leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor might lose its function. The primary function of this capacitor is to provide energy to store “Realtime Clock” information in case of total loss of power (external AC supply and battery) for example during storage.
As a result of the short circuit, affected HAMILTON-C1/T1/MR1 ventilators might switch to the “Ambient State.” In case of “Ambient State”, active ventilation is no longer provided to the patient. The device is constantly alarming audibly and visually.
A loss of “Realtime Clock” information does not have any severe consequence. This situation can only occur during startup of the ventilator. The “Realtime Clock” information needs to be set. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Device Technologies is contacting individual customers that have been identified as having these specific serials numbers of affected control boards installed. Device Technologies will be in contact to arrange replacement of the affected control boards.
In the interim if this issue occurs:
1. Provide alternative ventilation immediately.
2. Switch off ventilator power to exit the “Ambient State”.
3. Once patient safety is ensured, it is required to have the ventilator serviced.
For further information see chapter “Ambient State” in the respective Operator’s Manual. |
| Contact Information |
0427 016 075 - Nicholas Arnold (or 0428 773 850 - Naaman Nash) |