| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00104-1 |
| Product Name/Description |
qube Compact Monitor & XPREZZON Bedside Monitor
qube Compact Monitor shipped between 16 December 2013 and 15 December 2014
Catalogue number: 91390
ARTG number: 108755
XPREZZON Bedside Monitor shipped between 18 June 2014 and 13 January 2015
Catalogue number: 91393
ARTG number: 181195 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Spacelabs Healthcare has received multiple reports regarding the following:
- A failure to boot following power on or reset, resulting in monitor operation.
- Loss of network connectivity, which may result in;
- An inability to display alarms and data from the affected monitor on central stations and other bedside monitors, or
- A failure to transmit parameter and alarms from the affected monitor to system printers and Sapcelabs’ Intesys Clinical Suite retrospective database (including the Clinical Events Interface remote notification feature).
- Display of English language when previously configured for another language (the alarm messages displayed in the parameter waveform zone are not affected as these are stored on a command module and not on the monitor.
- Touchscreen failure where touching the screen does not produce the expected response.
This issue is caused by inadequate electrical contact on one of the printed circuit board assemblies.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A small number of printed circuit boards with the affected socket were also distributed to customers to facilitate repair of customer monitors. Medtel Pty Ltd will contact affected customers to schedule a convenient time to replace the PCBAs in in their facility. Meanwhile customers are advised the following:
- The reported issues occur mostly at initial power on of a monitor. Always check for proper operation (such as functionality of touchscreen, proper language, and network connectivity) when the monitor is first turned on.
- If the product is monitored via a central station, ensure the notification feature for monitoring communication loss is on. The capability is on by default.
- If a bedside monitor is not monitored via central station, check the bedside monitor frequently to ensure the display is functional.
- Do not rely solely on the monitor for critically ill patients. This action has been closed-out on 05/08/2016. |
| Contact Information |
1300 886 385 - Medtel Customer Support |