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Philips 'Effica' CM monitors Battery Management Software Release.

Posted on 28th January 2019

Urgent - Field Safety Notice

FSN 86000259A

Philips 'Effica' CM monitors Battery Management Software Release.

A problem has been detected with the Philips Efficia CM Monitors (CM10/12/100/120/150), that, if it were to re-occur, could pose a risk for patients or users. The Field Safety Notice is intended to inform 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 user

Philips has received a report in which a Philips Efficia CM monitor with lithium ion batteries that had exceeded the battery life expectancy had overheated/ignited.

The risk has been identified to those batteries which have exceeded their number of charging cycles (300) or when the battery capacity is below 80% of that of a new battery.

These batteries should be replaced when the number of charge-discharge cycles exceed 300 cycles or when the battery capacity is below 80% of that of a new battery, whichever comes first.

Philips is releasing a system software update for the Efficia CM monitors that will enhance the users’ ability to monitor battery condition over its lifetime and will alert users when it is time to replace the battery.

The affected products are all Efficia CM Monitors manufactured before Oct 25, 2018 that are capable of operating under battery power.

Specifically, the following Efficia CM Monitors with software revisions up to and including A.01.10 (Worldwide, excluding USA)

Product               Description

863300                       Efficia CM100

863301                       Efficia CM10

863302                       Efficia CM120

863303                       Efficia CM12

863304                       Efficia CM150

Problem Description

Philips has received a report in which a Philips Efficia Monitor (CM10/12/100/120/150) with lithium ion batteries that had exceeded its battery life expectancy and overheated/ignited. 

Hazard Involved

Overheating of a lithium ion battery may cause the device exterior case to become excessively hot, causing the case to melt and/or the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

HOW TO IDENTIFY AFFECTED PRODUCTS

You can determine whether your device is affected by identifying the Product number and software revision.  This can be performed by;

a) Locate and verify the Product Number of your Efficia CM Monitor, found on the cover page of the Instructions for Use or on the back label of your monitor, and b) Locate and verify the software revision in the monitor (System Menu / Software Version)

ACTION TO BE TAKEN BY CUSTOMER / USER

Customers/Users are advised to promptly perform the software upgrade to each of your Efficia monitors (CM10/12/100/120/150), as described in the Battery Management Software-Installation Instructions.  It details how to obtain and install the Battery Management software. It also provides instructions on how to export the file that is created during system software installation and instructions where and how to email the file to Philips.

Along with the software, the user will download the Instructions for Use Addendum and Service Guide Addendum.  Review this information with all staff members who are responsible for device management of the Philips Efficia CM monitors.  Please store the attached Addendums with your Philips Efficia CM Monitors Service Guide and Instructions for Use documentation. 

Should it be necessary, a replacement battery must be ordered. Details on how to replace the battery can be found in the Philips Efficia CM monitor Service Guide. 

Euro Energy appreciate the risk that these batteries could impose, and  that should you need to replace your batteries, you’ll want to do it fast! These batteries are a stock item, 02147, available for immediate delivery.

For further information, please contact our friendly & knowledgeable Customer Service team on 0116 2340567 or email info@euroenergy.co.uk to order your replacements!

Registered Name: Euro Energy Resources Limited
Registered Office: 10 Barrington Business Park, Leycroft Road, Leicester, LE4 1ET, UK
Global Location Number: 5060554170005 | Registered Number: 01576945 | VAT Number GB355306562