| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01124-1 |
| Product Name/Description |
Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)
Model Numbers: 802LTAN, 802LT0N
Serial Numbers: KA009946 to KA027084 and KL014918 to KL019440
ARTG Number: 123809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Internal product testing conducted by Welch Allyn has identified fault conditions relating to electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt Propaq LT device operations. If this event were to occur, the device would either present an error screen instructing the user to restart the monitor, or could instead present a blank or white screen. Either screen would be accompanied by one or more blinking LED lights, and in either case, the issue would be resolved by restarting (power cycling) the monitor. This issue is more likely to occur at higher energies such as 5kV. There is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the Propaq LT while the device is restarted. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Welch Allyn is providing work around instructions for users to follow if the error messages are displayed. A software update will be implemented to permanently correct the issue. |
| Contact Information |
02 9638 3000 - Welch Allyn Technical Support |