Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate (MDA/2019/027)
Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.
Action
- Initiate a process for sourcing an alternative defibrillator as these devices do not meet regulatory requirements for safety and performance.
- Complete a local risk assessment for the continued use of the affected devices until an alternative device is sourced.
- Report any problems you have with the mesh to the Yellow Card Scheme in England or the appropriate authority in Scotland, Northern Ireland and Wales
Action by
All medical, nursing and technical staff involved in the use and maintenance of these devices.
Deadlines for actions
Actions underway: 8 August 2019
Actions complete 22 August 2019
Problem/background
The CE certificate for Telefunken defibrillators was suspended in July 2016 and subsequently withdrawn in April 2017. Without a valid CE certificate, a manufacturer may not place its devices on the market. However, in this case the manufacturer continued to sell them.
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:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Adult intensive care units
- All departments
- All staff
- All wards
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Anti-coagulation clinics
- Audiology departments
- 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
- Chief pharmacists
- Chiropodists
- Clinical governance leads
- Clinical pathologists
- Clinical pathology directors
- Clinical perfusionists
- Cochlear implant units directors
- Colposcopy departments
- Community children’s nurses
- Community defibrillation officers
- Community dental practices
- Community diabetes specialist nurses
- Community hospitals
- Community midwives
- Community nurses
- Coronary care departments
- Coronary care nurses
- Day surgery units
- Dental departments
- Dental nurses
- Dentists
- Dermatologists
- Diabetes clinics/outpatients
- District nurses
- EBME departments
- ENT departments
- ENT medical staff
- ENT services, directors of
- Equipment stores
- Equipment libraries and stores
- Fracture clinics
- Gastroenterology departments
- Gastroenterology, directors of
- Gastro-intestinal surgeons
- General surgery
- General surgical units, directors of
- Gynaecologists
- Gynaecology departments
- Gynaecology nurses
- Haematologists
- Haemodialysis nurses
- Haemodialysis units
- Health and safety managers
- Hospital at home units
- 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
- IV nurse specialists
- Maintenance staff
- Minor injury units
- Maternity units
- Maxillofacial departments
- Medical directors
- Medical libraries
- Medical oncologists
- Medical oncology, directors of
- Medical physics departments
- Midwifery departments
- Midwifery staff
- MRI units, directors of
- Neonatal nurse specialists
- Neonatology departments
- Neonatology directors
- NHS walk-in centres
- Nursing executive directors
- Obstetricians
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Occupational health departments
- Occupational therapists
- Oncology nurse specialists
- Operating department practitioners
- Ophthalmic nurses
- Ophthalmology departments
- Ophthalmology, directors of
- 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
- Palliative care teams
- Paramedics
- Patient transport managers
- Peritoneal dialysis units
- Pharmaceutical advisors
- Physiotherapists
- Podiatrists
- Purchasing managers
- Radiation & medical oncology departments
- Radiation oncologists
- Radiation oncology, directors of
- Radiographer superintendents
- Radiographers
- Radiologists
- Radiology departments
- Radiology directors
- Rehabilitation engineers
- Renal medicine departments
- Renal medicine, directors of
- Resuscitation officers and trainers
- Risk managers
- School nurses
- Special care baby units
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
- Urology departments
- Walk-in centres
Public Health England
Directors for onward distribution to: * Collaborating centres * Consultants in communicable disease control * Divisional directors * Heads of department * Heads of health, safety and quality * Health protection nurses * PHE laboratories * Laboratory managers * Regional business managers * Regional directors * Regional epidemiologists * Regional leads * Regional microbiologists * Risk manager * Safety officers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- Community optometrists
- Community pharmacists
- Dispensing opticians
- General dental practitioners (for information only)
- General practitioners
- Occupational health departments
- Optometrists
- General practice managers
- General practice nurses
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
Social services
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team managers
- Children’s disability services
- Community care staff
- Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
- Disability equipment stores
- Education departments for equipment held in schools
- Environmental health officers
- Equipment stores
- Equipment supplies managers
- In-house domiciliary care providers (personal care services in the home)
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
- Occupational health departments
- Occupational therapists
- Schools with hoists
- Transport managers
- Wheelchair and seating service managers
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
- Domiciliary care providers
- Further education colleges registered as care homes
- Hospices
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- 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.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/027 or 2019/004/023/291/003.
Technical aspects
Paul Sandhu, MHRA Tel: 020 3080 6000
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
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, Social Services and Public Safety
Tel: 0208 9052 3868
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
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 250986 or 03000 255510
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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