| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01158-1 |
| Product Name/Description |
Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network
Serial Number: RM01940-F2
ARTG Numbers: 223386 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Mindray has identified an issue related to the Panorama Central Station where Full Disclosure data (includes patient data, waveforms, and events) may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray’s V-Series Monitor. The Full Disclosure data may be a minimum of 6 seconds behind the Panorama system time clock and may grow at a rate of 5 to 7 seconds per day if the V-Series Monitor remains connected to the Panorama Central Station without interruption.
This issue may also lead to the inability to print the most recent “Full Disclosure” data if the lag time exceeds 21 seconds. If the lag time exceeds 30 seconds, non-invasive blood pressure measurement contained in the “List Trends” may appear out of time order. There are no reports of injuries associated with these issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mindray is arranging software upgrade to eliminate this issue. Customers are advised that a break in communications, admitting or discharging a patient or putting the V-Series in standby will, temporarily, eliminate the issue. This action has been closed-out on 26/08/2016. |
| Contact Information |
02 9519 5881 - Mindray Medical Australia |