| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00676-1 |
| Product Name/Description |
IntelliVue MX40
Software Versions: B.00.x and B.01.x
Part Numbers: 865350 and 865352
ARTG Number: 99204 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Alarm Pause time is user selectable from 1 to 3 minutes, with a default of 2 minutes, when operating the MX40 with the PIIC iX.
When the following specific conditions are met, the Alarm Pause time does not automatically restart when it reaches its selected time limit:
- the Pause Alarms configuration is enabled in the non-default setting of both Red and Yellow level alarms;
- the MX40 is selected for the non-default setting of monitor mode;
- the Pause Alarms is initiated to pause an active alarm or to maintain a short ‘non-alarm’ state while in the patient’s vicinity; and
- an alarm condition occurs during the Pause Alarms time.
The MX40 will continue to display “Alarms Paused: 0:00” and the PIIC iX will display “Alarms Paused” until the Pause Alarms feature is disabled manually. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising their customers that the following two items must be configured when using the MX40 with the IntelliVue Information Center iX:
1. Utilise the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms.
2. Utilise the default state of Remote Suspend Alarms as off, which disables the use of the Pause Alarm feature of the MX40 device.
Philips will implement a software update to correct the issue. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |