| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00296-1 |
| Product Name/Description |
LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionality
Multiple Serial Numbers
EtCO2 module
Lot Codes: 1506, 1520, 1532, 1544, 1551
ARTG Number: 215648 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified where the EtCO2 reading on the LIFEPAK 15 can intermittently show a value of “XXX” after start-up or during device operation.
An investigation by the manufacturer of the EtCO2 module has revealed that compressed air may have contaminated filters within in the module. As a result of this filter contamination, the EtCO2 display on the device will provide a reading of “XXX”. There may be solid or dashed lines present on the device display in the place of an EtCO2 waveform and the SERVICE LED will be illuminated. In this situation the EtCO2 monitoring functionality will no longer be available. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Physio-Control is advising users who experience the “XXX” after power-up or during device operation to make immediate contact to arrange for servicing of the affected device. Users are further advised that if the issue does not occur, to continue performing the daily device self-tests as indicated in the Operating Instructions and the device is safe to use.
This action has been closed out on 05/11/2018 |
| Contact Information |
1800 987 982, Option 2 - Physio-Control |