- Identify affected ventilators.
- Have systems in place to ensure that:
- users, including patients and carers, understand the problem detailed in the manufacturer’s Field Safety Notice follow the manufacturer’s advice
- an external battery is connected if the ventilator is used as a mobile unit
- an additional external power source and backup source of ventilation is available at all times
- once available, the warning sticker is put on affected ventilators
- ventilators and external batteries are returned to a service centre for routine maintenance when prompted
- Return the Field Safety Notice acknowledgement form to ResMed.
All healthcare workers and carers who use these devices.
Deadlines for actions
Actions underway: 2 weeks
Actions complete: 2 months
All internal, external and spare batteries are potentially affected by this problem.
The RPSII battery is not affected.
alternative batteries have been developed. Affected batteries are not being recalled.
batteries will be replaced within the 2-year maintenance period, prioritised according to need. Customers who are concerned about the clinical need of their patients should contact ResMed directly.
updating the user and clinical guides to advise on the safe use of Astral ventilators when not on AC power.
The internal battery is designed to deliver continuous power when the external power source is disrupted.
It is not intended to serve as a primary power source.
Although both internal and external batteries are potentially affected, using both at the same time reduces the risk of power loss as it is highly unlikely that both sets of batteries will fail at the same time.
ResMed (UK) Ltd
Tel: 01235 862 997 Option 3
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Anaesthesia, directors of
- Anaesthetic medical staff
- Community children’s nurses
- Community nurses
- District nurses
- EBME departments
- ENT departments
- Equipment libraries and stores
- Health and safety managers
- Hospital at home units
- Intensive care units
- Paediatric intensive care units
- Patient transport managers
- Risk managers
- Supplies managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team members
- Community care staff
- Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
- 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
- Transport managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Domiciliary care providers
- Hospitals in the independent sector
- Nursing agencies
- Private medical practitioners
Establishments registered with OFSTED
- 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 Department of Health’s Central Alerting System (CAS) by sending an email to: <email@example.com. and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/yyyy/nnn or 2017/006/006/291/017.
Emma Rooke or Suleman Hussain, MHRA
Tel: 020 3080 6609/6956
Email: firstname.lastname@example.org or email@example.com
Dr Kate Antrobus, Clinical Advisor, Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NICAS 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
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
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
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
MDA/2017/029 - 2017/006/006/291/017