Philips HeartStart MRx M3538A Battery Field Safety Notice (FSN) 86100195B
Here at Euro Energy, we are pleased to confirm to all of our Customers that none of the batteries sold by Euro Energy are affected.
Today, Friday 23rd November 2018 Philips issued the following Field Safety Notice (FSN):
URGENT – Field Safety Notice Certain Philips HeartStart MRx M3538A Batteries May Fail to Function
Dear Customer,
Philips discovered that certain M3538A Lithium-Ion Batteries manufactured between December 28, 2017 and March 20th, 2018 for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power due to an internal component failure.
Philips is providing this Field Safety Notice to inform you about:
Issue and under what conditions it can occur
Actions that you should take to mitigate risk to patients
The following pages provide information on how to identify affected devices and instructions on actions to be taken. Follow the “ACTION TO BE TAKEN BY CUSTOMER / USER” section of the notice.
URGENT – Field Safety Notice Certain Philips HeartStart MRx M3538A Batteries May Fail to Function
AFFECTED PRODUCTS
Product: M3538A Lithium-Ion Batteries for the HeartStart MRx Monitor/Defibrillator.
Units Affected subject to this Recall: A total of 1,880 Lithium-Ion Batteries manufactured between December 28, 2017 and March 20, 2018 with serial numbers 17362-0001-P through 18057-0266-P
HOW TO IDENTIFY AFFECTED PRODUCTS
The serial number of the rechargeable lithium-ion battery is printed on the label on the back of the battery.
BEHAVIOR DESCRIPTION
Affected MRx M3538A lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the MRx Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the HeartStart MRx, the battery failure may go unnoticed.
HAZARD INVOLVED
If the MRx is being operated with a failed lithium-ion battery, the HeartStart MRx will no longer function, potentially delaying shock therapy or interrupting monitoring or pacing, which could result in reduced survival from a cardiac event.
ACTION TO BE TAKEN BY CUSTOMER / USER
Inspect the batteries installed in your MRx monitor/defibrillator to determine if they are affected by this recall. If any affected batteries are found, remove them from service immediately, along with any other affected batteries in your inventory.
Your MRx monitor/defibrillator can only be returned to service once a charged battery, unaffected by this recall, is installed.
Removed batteries should be disposed in accordance with local regulations. Do not return affected batteries to Philips.
ACTIONS PLANNED BY PHILIPS
Users with affected batteries should contact Philips Customer Care team & Philips will replace affected HeartStart MRx M3538A Rechargeable Lithium-Ion Batteries at no charge to the User when replacement batteries are available.
