| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01173-1 |
| Product Name/Description |
Mindray's V-Series Patient Monitors, software versions 2.4.0.18, 2.4.0.50, 2.4.0.60 and 2.4.1.18
Model Numbers: 1412 & 1414
Serial Numbers: EGL19008969, EGL1B009996, EGL1B010000, EGL1B010014, EGL1B010016, EGL1B010341, EGL1B010352, EGL1C010807
ARTG Numbers: 223384 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Mindray has identified an issue that involves the V-Series Drug Calculator function specific to weight based calculations. This issue may occur when the patient’s weight is entered using either the V-Series Patient Information dialog or the Panorama Central Station (if it's in use with the Central Station). If the weight is manually entered, the issue will not occur. Depending on the version of software in use, the most recent weight entered into the V-Series Patient Setup dialog or the Panorama Central Station may not be received by the calculator feature; the calculator may retain the original weight entered. Additionally, the weight that is displayed in the Drug Calculator dialog may not reflect what was used for the calculation.
If an incorrect dosing calculation results and medication is administered, immediate and/or long term health consequences may result depending on drug, dose, and duration.There are no reports of injuries associated with these issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mindray is recommending that customers discontinue use of the Drug Calculator function until the software correction is performed. This action has been closed-out on 26/08/2016. |
| Contact Information |
02 9519 5881 - Mindray Medical Australia |