Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery

Manufactured by ResMed – If operated only by the internal battery and this fails, the patient will not be ventilated.

Action

  • 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.

Action by

All healthcare workers and carers who use these devices.

Deadlines for actions

Actions underway: 2 weeks

Actions complete: 2 months

Devices details

All internal, external and spare batteries are potentially affected by this problem.
The RPSII battery is not affected.

Background

ResMed’s actions:

  • 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.

Manufacturer contacts

ResMed (UK) Ltd Tel: 01235 862 997 Option 3 Email: astralbatterysupport@resmed.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 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
  • Paediatricians
  • Patient transport managers
  • Risk managers
  • Supplies managers

NHS England area teams

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

  • General practitioners

Social services

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

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)
  • 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: <safetyalerts@dh.gsi.gov.uk. and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/yyyy/nnn or 2017/006/006/291/017.

Technical aspects

Emma Rooke or Suleman Hussain, MHRA

Tel: 020 3080 6609/6956

Email: emma.rooke@mhra.gov.uk or suleman.hussain@mhra.gov.uk

Clinical aspects

Dr Kate Antrobus, Clinical Advisor, Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: dct@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

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

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please 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: 02920 823 624 / 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/2017/029 - 2017/006/006/291/017 MDA/2017/029 - 2017/006/006/291/017

Published 12 September 2017