| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01163-1 |
| Product Name/Description |
Philips IntelliVue Patient Monitors and Philips Avalon Fetal Monitors
IntelliVue Patient Monitors, software versions J.21.03 & J.21.19
Models and Product Numbers: MP5 (M8105A), MP5SC (M8105AS), MP5T (M8105AT), MP5 Upgrade (M8105AU), MP5SC Upgrade (866327)
ARTG Number: 94238
Avalon Fetal Monitors, software version J.30.58
Models and Product Numbers: FM20 (M2702A), FM30 (M2703A), FM50 (M2705A)
ARTG Number: 99202 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
In time-synchronized automatic/sequence mode the noninvasive blood pressure (NBP) automatic measurement series is stopped inadvertently, if the repetition interval is increased manually by the user (e.g. from 5 to 15 minutes) in between two consecutive measurements.
- A prompt message “Any ongoing NBP measurement and automatic cycle stopped” is displayed and a single tone sounds when the measurement series is stopped.
- After the automated measurement series has been stopped, NBP numeric, repetition time, and time to next measurement are no longer displayed, i.e. the NBP numeric field is blank.
If the NBP measurement is stopped, and a patient’s blood pressure is not being monitored, a delay in treatment could occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips Healthcare representative will contact customers with affected devices to arrange a software upgrade to correct the issues. During the interim period until the SW is upgraded, customers are advised to make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |