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Philips Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20/11/18 & Philips Effica monitors (CM10/12/100/120/150) manufactured before 25/10/18 subject to MHRA Alert

Posted on 21st March 2019
Philips Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Effica Monitors (CM10/12/100/120/150) manufactured before 25 October 2018: risk of batteries overheating or igniting - GOV.UK update – MHRA issued 20/3/19
 
At 11.00am on the 20th March 2019, the MHRA published an email alert, MDA/2019/017 advising of a potential risk of overheating or ignition of the lithium ion batteries (Philips part number 989803194541) used in the Philips Pagewriter Cardiographs (TC20/30/50/70) and Effica Monitors (CM10/12/100/120/150).
 
The problem affects lithium ion batteries that have exceeded their replacement interval, have exceeded 300 charge-discharge cycles or battery health has fallen to less than 80%.
 
Euro Energy appreciate the risk that these batteries could impose, and we understand that should you need to replace your batteries, you’ll want to do it quickly. Stock of Philips battery number 989803194541, Euro Energy part number 02147 is available on shelf for immediate delivery, should you identify batteries that need immediate replacement. After all, at Euro Energy, excellent customer service and fast delivery is what we strive for.
 
To order your Philips Pagewriter Cardiograph (TC20/30/50/70) or Philips Effica Monitor (CM10/12/100/120/150)  batteries (Philips part number 989803194541, our part number 02147), contact our friendly & knowledgeable Customer Service Team on 0116 234 0567 or email info@euroenergy.co.uk
 
Full details of the MHRA can be found by following the link below and downloading the MDA/2019/017 pdf:-
 
Action
Identify all affected devices using the manufacturer’s Field Safety Notices (FSNs) for the TC Cardiograph and the Effica monitor.
For TC Cardiographs:
  • Check if the battery has exceeded the 300 charge-discharge cycles or if the battery health (capacity) is less than 80%. If necessary replace the battery in accordance with the instructions in the FSN – new 989803194541 batteries can be obtained from Euro Energy by calling 0116 234 0567 or emailing info@euroenergy.co.uk and asking for part 02147.
  • Ensure that systems are in place to routinely monitor battery condition. Philips are developing a software update that will assist in battery management and will contact you once this is available.
For Effica Monitors:
  • Install the software update (version A.01.11) described in the FSN
  • Once installed, the device will indicate via an error message if battery replacement is necessary. These can be obtained from Euro Energy by calling 0116 234 0567 or emailing info@euroenergy.co.uk
Report adverse incidents involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate:   England, Scotland, Northern Ireland, Wales
 
Action By
All medical, nursing and technical staff involved in the use and maintenance of these devices.
 
Deadlines
Actions underway: 10 April 2019
Actions complete:  01 May 2019
 
A previous medical advice alert MDA/2018/0031 was published for the same issue in Philips Suresigns VS and VM patient monitors and viewing stations manufactured before 3rd May 2019 – read our blog here – if you have these devices, please ensure that the actions described in that MDA have been completed.
 
Please note that operators of Care Homes, Independant Healthcare providers, private medical practitioners, clinics and hospices can sign up to receive Medical Device Alerts (MDAs) directly from the Central Alerting System (CAS) by sending an email to safetyalerts@mhra.gov.uk and requesting this facility.
 
Remember – if you need to order replacement batteries for these devices (Philips part number 989803194541, our part number 02147), for any other Philips equipment 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
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