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Field Safety Notice - Philips Intellivue MX40 989803174131 / 989803176201 - Increased Battery power Consumption and Absence of Low Battery Alarms

Posted on 2nd July 2019

Field Safety Notice - Philips Intellivue MX40 989803174131 / 989803176201 - FSN86201863C

Increased Battery power Consumption and Absence of Low Battery Alarms

On June 19, 2019 Philips Healthcare released an urgent Field Safety Notice, FSN86201863C, regarding the Philips Intellivue MX40 entitled 'Increased Battery Power Consumption and Absence of Low Battery Alarms, text below:-

Dear Customer, 
 
Previously, you received notices related to power consumption and battery alarms of the MX40, including the original letter dated March 22, 2019. Subsequent to these communications, additional issues related to power consumption and low battery alarms have been found.  This letter supersedes the prior notices with respect to the “Actions to be Taken by the Customer/User“ to prevent risks to patients.  As mentioned previously, Philips will be contacting you to arrange for a software upgrade and the installation of the software upgrade will correct these problems. 
 
This Medical Device Recall letter is intended to update you about:
  • what the problem is and under what circumstances it can occur
  • the actions that should be taken by the customer / user in order to prevent risks for patients or users
  • the actions planned by Philips to correct the problem. 

This document contains important information for the continued safe and proper use of your equipment 

Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. 
 
Please retain a copy with the equipment Instruction for Use.
 
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a “Low Battery State”.   
 
This notice will be reported to the appropriate regulatory agencies. 
 
Philips apologizes for any inconvenience caused by this problem.
 
AFFECTED PRODUCTS: All Philips IntelliVue MX40 Patient Worn Monitors. 
PROBLEM DESCRIPTION: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a “Low Battery State”. 
HAZARD INVOLVED: The patient and nearby caregivers may not realize that monitoring has been lost and the battery should be replaced, which may result in a delay in recognition of the need for therapy and/or therapy delivery. 
HOW TO IDENTIFY AFFECTED PRODUCTS: This action applies to all MX40 units.   
ACTION TO BE TAKEN BY CUSTOMER / USER: Until you have upgraded the software on your MX40, replace your batteries every 8 hours, unless you are using Monitor Mode and SpO2 measurement (Manual, Continuous or Auto modes) with AA batteries, in which case replacement should be done every 2 hours. Please complete the attached Reply Card and return to Philips as soon as possible. 
ACTIONS PLANNED BY PHILIPS: Philips Healthcare has released a software upgrade (MX40 rev B.06.59), which will correct these problems. Philips will contact you to arrange for software correction. 
 
If you need to purchase additional batteries, please contact Euro Energy on 0116 2340567 or email info@euroenergy.co.uk. MX40 batteries are sold as either a 3 pack, Euro Energy Part Number 02214, Philips Part Number 989803174131 or as singles, Euro Energy Part Number 02396, Philips Part Number 9898803176201.
 

For further information or to discuss our range of Original Manufacturer medical batteries & Compatible medical batteries, Original Manufacturer medical accessories and general purpose Sealed Lead Acid/VRLA batteries contact our friendly & knowledgeable Customer Service team on 0116 2340567 or email info@euroenergy.co.uk

Registered Name: Euro Energy Resources Limited
Registered Office: 10 Barrington Business Park, Leycroft Road, Leicester, LE4 1ET, UK
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