Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039)
Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.
Action
- Identify affected devices in your organisation.
- Ensure that:
- staff are aware of the recommended actions in the manufacturer’s Field Safety Notice (FSN)
- you have ready access to a backup defibrillator until the software and hardware upgrades have been undertaken by Philips
- you have systems in place to arrange for the upgrades to be implemented.
- Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Action by
All medical, nursing and technical staff involved in the use and maintenance of these devices.
Deadlines for actions
Actions underway: 14 November 2019
Actions complete: 28 November 2019
Medical Device Safety Officers (in England):
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.
Manufacturer contacts
For technical queries call UK Philips Customer Care Service Centre on 0870 532 9741
To confirm receipt of the FSN, email safetynoticeuki@Philips.com
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- All departments
- All staff
- All wards
- Ambulance services directors
- Ambulance staff
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General dental practitioners
- General practice managers
- General practice nurses
- Occupational health departments
Social services
Liaison officers for onward distribution to all relevant staff including:
- Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
- Education departments for equipment held in schools
- Equipment stores
- Equipment supplies managers
- In-house residential care homes
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Clinics
- Further education colleges registered as care homes
- Hospices
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
Establishments registered with OFSTED
- Children’s services
- Educational establishments with beds for children
- Residential special schools
Please 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 Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/039 or 2019/008/015/487/030.
Technical aspects Paul Sandhu or Andy Marsden, MHRA Tel: 020 3080 6000 Email: DSS-TM@mhra.gov.uk
Clinical aspects Devices Clinical Team, MHRA Tel: 020 3080 7274 Email: dct@mhra.gov.uk
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)
Tel: 0208 9052 3868
Email: niaic@health-ni.gov.uk
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can't access the webform, visit the website: how to report an adverse incident
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 255278 / 03000 255510
Email: Haz-Aic@gov.wales
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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