| TGA Action ID |
RC-2026-RN-00372-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Hamilton Medical IntelliCuff Pressure Controller
Product Code: HMT-951001
Part Number: 951001 (*Standalone only)
Serial numbers smaller than 19732
Only IntelliCuff (Standalone) devices, also known as IntelliCuff Handheld devices, are in the scope of this action. IntelliCuff devices integrated into HAMILTON-C6 are not in the scope of this action. |
| ARTG Number |
287802 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The cuff connector may crack if excessive force is applied when connecting the cuff pressure tube or if an accidental drop occurs during handling of the device. In some cases, such cracking may lead to a leakage which may result in a reduction or loss of the cuff pressure, also referred to as cuff system leakage.
If the leakage remains undetected during use, there is potential for oxygen desaturation or aspiration pneumonia for the patient. However, within complaint data of almost 10 years (2016-2026), no serious injuries or deaths have been reported in relation to a leaking cuff. The reported problem would trigger a "cuff system leakage" alarm, alerting personnel. |
| Instructions for Customers/Users |
In case of “Cuff system leakage” alarm, the user is requested to perform the following steps:
1. Check applied pressure settings, cuff pressure tube, ETT tubing, and all connections.
2. If leakage persists, make sure the cuff is blocked properly (manually) and the patient does not aspirate. Switch off the IntelliCuff.
3. Once patient safety is ensured, the device must be taken out of service. The IntelliCuff must be serviced by trained and certified personnel before being returned to use.
For further information, refer to Chapter 7 (Alarms and troubleshooting) of the IntelliCuff Instructions for use (PN 624741/07).
An improved cuff connector will be provided for all affected devices to correct the problem with the IntelliCuff device. Replacement cuff connectors are expected to be available from July 2026. A DT representative will be in contact to arrange the correction of affected devices once replacements are available. |
| Action Commencement Date |
18/05/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies Australia |