Product Alert | Philips HeartStart MRx Monitor/Defibrillator (MDA/2020/016)

This article has been brought to you by Slough Borough Council's Service Lead for Schools, Johnny Kyriacou on behalf of Slough Borough Council's Senior H&S Adviser, Victoria Swift. This is for the attention of the all schools.

It has been brought to our attention that the Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock. If you have this equipment then please follow the instructions below.

Action

  • Identify monitors/defibrillators affected by the manufacturer’s Field Safety Notice here.  
  • Perform a manual operational check immediately if the monitor/defibrillator is dropped or subject to severe mechanical shock
  • Ensure alternative devices are available as defined in the local risk assessment procedures if an affected device is removed from service
  • Insert a copy of the Field Safety Notice into each copy of the HeartStart MRx Instructions for Use
  • Contact Philips to confirm receipt of their Field Safety Notice if your device is listed as being affected

Manufacturer Contacts

Philips Customer Care Service Centre

Tel | 0870 532 9741

Email | safetynoticeuki@philips.com

Quote Philips Reference Number | FCO86100198

In addition to this ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.

Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

If you require any further assistance, please do not hesitate to contact the Corporate Health and Safety Department on 01753 875 046 or alternatively send an email to HealthandSafety@slough.gov.uk.

Health and Safety Team:

H&S inbox healthandsafety@slough.gov.uk   

Tel: 01753 875742 or 01753 875046

Bhavini Ranu Bhavini.Ranu@slough.gov.uk  

Vicki Swift Victoria.swift@slough.gov.uk

Gina Watson Georgina.Watson@slough.gov.uk

Shameem Din | Shameem.din@slough.gov.uk