- Medicines and Healthcare products Regulatory Agency
- 3 August 2016
- 3 August 2016
- Alert type:
- Medical device alert
Manufactured by Draeger Medical – Return ventilation circuits manufactured up to and including March 2016 as they may leak at the check valve.
Identify and quarantine affected circuits.
Return all affected devices to Draeger UK for replacement, free of charge.
If you have already disposed of affected stock, inform Draeger UK for replacement.
Contact Draeger UK to acknowledge receipt of the FSN (dated 20/05/2016), even if you don’t have affected devices left in stock.
If no alternative devices are available, carry out a risk assessment and follow the guidance in Draeger’s FSN
All healthcare workers who use these devices.
Deadlines for action
Actions underway: 17 August 2016
Actions complete: 03 October 2016
Part number 5704964
All devices manufactured up to and including March 2016 are affected.
In their global FSN, Draeger asked customers to dispose of affected devices.
Helen Glass, Customer Services / Quality Department,
Draeger Medical UK Limited
Tel: 01442 292870
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 departments
- Ambulance services directors
- Ambulance staff
- Anaesthetic medical and nursing staff
- Clinical governance leads
- Day surgery units
- Dental departments
- Health and safety managers
- Intensive care medical and nursing staff (paediatrics)
- Intensive care units
- Medical directors
- Medical libraries
- Neonatal nurse specialists
- Neonatology departments
- Neonatology directors
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric wards
- Paediatrics departments
- Resuscitation officers and trainers
- Risk managers
- Special care baby units
- Supplies managers
- Theatre managers
- Theatre nurses
Public Health England
Directors for onward distribution to:
- Risk manager
- Safety officers
NHS area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practice managers
- General practice nurses
Liaison officers for onward distribution to all relevant staff including:
- Equipment stores
- Equipment supplies managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
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: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/012 or 2016/005/026/291/008.
Emma Rooke and Dr Devendra Deo, MHRA
Tel: 020 3080 6609 / 6265
Dr Soundararajan Jagdish, MHRA
Tel: 020 3080 7187
Reporting adverse incidents in England
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,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland
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 - NHS Boards and Local Authorities in Scotland – report to Health Facilities 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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 3 August 2016
Issued: 3 August 2016
Alert type: Medical device alert