PadPro and R2 multifunction electrodes - risk of delay to shock

(Conmed) Risk of delay to shock as specific electrodes manufactured by Conmed are now incompatible with some models of Philips defibrillators (MDA/2015/010)

Action

  • ensure staff are aware of the information contained in the field safety notice (FSN)
  • identify any affected product as listed in the FSN
  • ensure that the affected electrodes are not placed with Philips Heartstart FR3 defibrillators and FRx AEDs

Action by

All staff responsible for the use, storage and purchase of these devices

Deadlines for actions

Actions underway: 26 March 2015, actions complete:10 April 2015

Device details

PadPro multifunction electrodes:

Catalogue number Device name Lot code
2001H Adult Radiotransparent Electrode All lot codes
2001H-C Adult Radiotransparent Electrode All lot codes
2001H-PC Adult Radiotransparent Electrode All lot codes
2516H Adult Radiotranslucent Electrode All lot codes
2516H-PC Adult Radiotransparent Electrode All lot codes
2603H Pediatric Radiotranslucent Electrode All lot codes
2602H Mini Pediatric Radiotranslucent Electrode All lot codes

R2 multifunction electrodes:

Catalogue number Device name Lot code
3115-1750 Pediatric R2 Multifunction Electrode All lot codes
3110-1751 R2 Multifunction Electrode All lot codes

Problem / background

Philips Healthcare has made changes to the design of the connection between electrodes and the defibrillator so some Conmed electrodes are no longer compatible.

This MDA is for information only and no product needs to be returned to Conmed.

The labelling on new electrodes has been updated to show compatibility.

Manufacturer contacts

Gregory Connell
ConMed Corporation
Tel: +1 727-399-5276

Email: multifunctionelectrodes@conmed.com

Distribution

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts

CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E consultants
  • A&E departments
  • A&E directors
  • A&E nurses
  • Adult intensive care units
  • All wards and departments
  • Ambulance services directors
  • Ambulance staff
  • Biomedical engineering staff
  • Biomedical science departments
  • Cardiac laboratory technicians
  • Cardiac pacing technicians
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Cardiothoracic surgery directors
  • Clinical governance leads
  • Clinical perfusionists
  • Community children’s nurses
  • Community defibrillation officers
  • Community dental practices
  • Community hospitals
  • Community midwives
  • Community nurses
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • Dental departments
  • Dental nurses
  • Dentists
  • District nurses
  • EBME departments
  • Equipment libraries and stores
  • Equipment stores
  • Health and safety managers
  • In-house maintenance staff
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Intensive care, directors of
  • Maintenance staff
  • Maternity units
  • Medical directors
  • Medical physics departments
  • Midwifery departments
  • Midwifery staff
  • Minor injury units
  • NHS walk-in centres
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatric intensive care units
  • Paediatric medicine, directors of
  • Paediatric nurse specialists
  • Paediatric oncologists
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Paediatric wards
  • Paediatricians
  • Paediatrics departments
  • Paramedics
  • Patient transport managers
  • Peritoneal dialysis units
  • Purchasing managers
  • Resuscitation officers and trainers
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres
  • Walk-in centres

NHS England area teams

CAS liaison officers for onward distribution to all relevant staff including:

  • General Practitioners
  • General Practice managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Care homes providing nursing care (adults)
  • Care homes providing personal care (adults)
  • Clinics
  • Hospitals in the independent sector
  • Independent treatment centres
  • Private medical practitioners

Note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2015/010 or 2014/011/012/081/016

Technical aspects

Paul Sandhu, MHRA
Tel:020 3080 7266

Email:paul.sandhu@mhra.gsi.gov.uk

Yasser Zayni, MHRA
Tel: 020 3080 7238

Email: yasser.zayni@mhra.gsi.gov.uk

Clinical aspects

Camilla Fleetcroft, MHRA
Tel:020 3080 6097

Email: camilla.fleetcroft@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS system. Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel:028 9052 3868
Fax:028 9052 3900

Email:NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Reporting adverse incidents in Northern Ireland

Report directly to NIAIC using the forms on our website.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
Fax:0131 314 0722

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division
Welsh Government
Tel: 01267 225 278 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA/2015/010 - PadPro and R2 multifunction electrodes

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.