BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment

Manufactured by Intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.

Action

  • Identify all affected devices – see details below.
  • Search for alternative devices to replace affected products (see appendix), and until alternative devices are available follow the guidelines in the Field Safety Notice.
  • Once you have alternatives, quarantine the affected devices and contact Intersurgical.

Action by

  • All those involved in the procurement and use of these device.

Deadlines for actions

Actions underway: 28 June 2017

Actions complete: 19 July 2017

Device details

The following model (REF number) and LOT numbers are affected:

REF number LOT number NHS Supply Chain Code
7150000, 7151000, 7151001, 7152000, 7152007, 7152060, 7153000, 7154000, 7155000, 7156000 All lot numbers up to and including lot 370253 7150000 is FDE656, 7152000 is FDE658, 7153000 is FDD4288
7152003 All lot numbers up to and including lot 1170673 n/a
7150006, 7151006, 7152004, 7152005, 7152006, 7152009, 7152012, 7152014, 7152061, 7153006, 7153008 All lot numbers up to and including lot 31753734 n/a
7150170, 7151170, 7152170, 7152172, 7153170 All lot numbers up to and including lot 170504 n/a

Manufacturer contacts

Chris Randall
Intersurgical

Telephone: 0118 9656 362

Fax: 0118 9656 356

Email: priority@intersurgical.co.uk

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:

  • A&E consultants
  • A&E departments
  • A&E directors
  • A&E nurses
  • Adult intensive care units
  • All wards
  • Ambulance services directors
  • Ambulance staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Biomedical engineering staff
  • Biomedical science departments
  • Cardiac laboratory technicians
  • Cardiology departments
  • Community children’s nurses
  • Community defibrillation officers
  • Community hospitals
  • Day surgery units
  • District nurses
  • EBME departments
  • ENT departments
  • Equipment stores
  • Equipment libraries and stores
  • General surgery
  • Hospital at home units
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Intensive care, directors of
  • Minor injury units
  • Maternity units
  • Medical directors
  • Neonatology departments
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatric intensive care units
  • Paediatric surgery, directors of
  • Paediatric departments
  • Paramedics
  • Patient transport managers
  • Purchasing managers
  • Radiology departments
  • Resuscitation officers and trainers
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatre practitioners/ Operating department practitioners
  • Theatres
  • Walk-in centres

NHS England area teams

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

  • General practitioners

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospitals in the independent sector
  • Independent treatment centres

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/2017/017 or 2017/005/031/291/005.

Technical aspects

Suleman Hussain or Hiten Patel, MHRA

Tel: 020 3080 6956 or 020 3080 6115

Email: suleman.hussain@mhra.gov.uk or hiten.patel@mhra.gov.uk

Clinical aspects

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 NI SABS 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/2017/017

Published 21 June 2017