| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01088-1 |
| Product Name/Description |
MAQUET HCU 30 Base Unit
Heater-Cooler Unit 30 with Serial Number < 93101480
HCU 30 Base Unit 100 -120 V, article number 704629 / 70103.4371
HCU 30 base unit 200 -240 V, article number 704631 / 70103.4642
HCU 30 base unit Canadian/US, article number 705501 / 70103.4653
ARTG Number: 144010 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
MAQUET Cardiopulmonary has received complaints associated with a failure of the power supply board of the HCU 30. An internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the NTC (Negative Temperature Coefficient) R56 thermistor of the power supply board.
An internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the R56 thermistor of the power supply board of the HCU 30 Type 2. A defective R 56 thermistor results in an inoperable compressor, the inability to actively cool the water or an inoperable HCU 30.
There are no complaints reported associated with a patient injury or death. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are asked to always keep a replacement unit on standby in order to ensure continuous operation in the event of a complete system failure, whilst the new power supply board which is equipped with a more robust NTC R56 thermistor is being installed. This action has been closed-out on 25/08/2016. |
| Contact Information |
1800 605 824 - Maquet |