| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00979-1 |
| Product Name/Description |
Defibrillator/pacer SLIM corpuls3
Product Code CP-4301
ARTG Number: 192745 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Due to too little distance between a circuit board and the housing, there is the possibility that a component on that circuit board could be damaged mechanically. This impairs the radio connection between the modules. The user can recognise this, if a respective error message (ie, “No connection to defibrillator unit” or “No connection to P-Box” ) is displayed. Impairment of the radio connection between the modules could result in the inability to:
- Perform full patient monitoring; and
- Correctly adjust and operate a therapy function of the device.
Vibrations have been found to increase the likelihood of this malfunction. Due to this issue, diagnosis and therapy are delayed, because the measurement and therapy functions cannot perform without problems. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies Australia (DTA) is advising the customer to connect the module mechanically to form a compact device if the error message is displayed. A permanent correction of the error is only possible by replacing the affected radio module. DTA is arranging replacement of the radio module. This action has been closed-out on 1/06/2016. |
| Contact Information |
02 9975 5755 - Device Technologies |