| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00946-1 |
| Product Name/Description |
CARDIOHELP-I (Heart-lung bypass system)
Serial numbers affected: 90140472, 901404544, 90410553
ARTG Number: 179104 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
MAQUET Cardiopulmonary has determined that in certain rare instances the Cardiohelp-I device may display an error message with audible alarm indicating "battery defective". The alarm will occur while booting or when the main power supply is unplugged from the main power source. This is due to a defective capacitor within the Battery Manager board. Further, when alarming the HMI (human machine interface) will gradually become black due to the HMI back light shutting down. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is advising the customers to only use the Cardiohelp-I on AC power when possible. In the event of a battery defect alarm the AC power should be connected immediately. An upgrade to the sensor panel will be carried out to correct the issue. |
| Contact Information |
1300 304 372 - Maquet Australia |