| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01172-1 |
| Product Name/Description |
Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities
V-series Model Numbers: 1409 & 1410
Serial Numbers: EGD16006409, EGD13004678 & EGD0B002460
ARTG Numbers: 223384 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Mindray has identified the following issues:
- The 12-lead Standard and Extended Measurement Report will include false measurements when the P wave or QRS axis cannot be accurately determined by the algorithm.
- The Median Complex and Extended Measurement Report will display the representative beat as 25% larger than actual signal input.
- When a patient date of birth is imported into the V-Series from an external source, such as Mindray’s Gateway, e-Gateway, Panorama Central Station or Panorama WorkStation, the age will not pass into the 12-lead ECG interpretation algorithm. The algorithm analysis will use the default adult criteria of “50 year adult” in which case the interpretive statements may be incorrect, depending on the actual age of the patient.
Any output of the 12-lead ECG interpretation data (e.g. printed records, ECG management system, etc.) will include the issues described above. There have been no reports of injuries associated with these issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mindray is recommending that users discontinue use of the affected units until the software correction is completed. This action has been closed-out on 26/08/2016. |
| Contact Information |
02 9519 5881 - Mindray Medical Australia |