Action

Check all stock for affected devices listed in the manufacturer’s Field Safety Notice (FSN).

Replace internal memory/alarm battery if it has not been replaced in the past 3 years.

Ensure that all ventilators are serviced by a trained engineer on a 12-month schedule.

Ensure that all staff are trained to use the device according to the latest version of the instructions for use. This can be found on the Breas Medical website.

Complete and return the response form attached to the FSN.

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

Clinical engineering/EBME department

All clinical users

Deadlines for actions

Actions underway: 22 January 2020

Actions complete: 26 February 2020

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 the MHRA.

Problem / background

The manufacturer has updated the instructions for use for this device. The update requires the internal memory/alarm battery to be replaced every 3 years. If this battery is depleted the device will alarm to inform the user of the need to change the battery.

The MHRA decided to issue this alert due to the low response rate from users to the manufacturer’s Field Safety Notice (FSN).

Name of manufacturer: Breas Medical Limited Jeremy.day@breas.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:

Adult intensive care units

Ambulance services directors

Ambulance staff

Anaesthesia, directors of

Anaesthetic medical staff

Anaesthetic nursing staff

Anaesthetists

Community hospitals

Community nurses

EBME departments

Equipment stores

Equipment libraries and stores

Hospital at home units

In-house maintenance staff

Medical physics departments

Palliative care teams

Paramedics

Patient transport managers

Risk managers

Social services

Liaison officers for onward distribution to all relevant staff including:

Care at home staff

Community care staff

Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)

Equipment stores

In-house domiciliary care providers (personal care services in the home)

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)

Domiciliary care providers

Further education colleges registered as care homes

Hospices

Hospitals in the independent sector

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 Central Alerting System (CAS) by sending an email to: safetyalerts@dmhra.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to the MHRA, quoting reference number MDA/2020/001 or 2019/010/018/291/001

Technical aspects

Ben Satchell, Emma Rooke 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),

Department of Health, Social Services and Public Safety



Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

https://www.health-ni.gov.uk/niaic

To report an adverse incident involving a medical device in Northern Ireland use the forms on our website.

Alerts in Northern Ireland are distributed via the NICAS system.

Scotland

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

Incident Reporting and Investigation Centre (IRIC),

Health Facilities Scotland,

NHS National Services Scotland



Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

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

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

NIPPY ventilator range (all models) – update to instructions for use (MDA/2020/001)