Oxylog 3000 and Oxylog 3000 plus ventilator – risk of failure

Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).

From:
Medicines and Healthcare products Regulatory Agency
Published
8 February 2017
Message type:
Device safety information
Medical specialty:
Anaesthetics, Critical care, Paediatrics
Issued:
8 February 2017

Action

  • Identify all Oxylog 3000 and Oxylog 3000 plus ventilators.

  • Ensure all users are aware of the Manufacturer`s Field Safety Notice (FSN) and know how to perform the pre-use check outlined in the instructions for use (IFU).

  • Contact Dräger to acknowledge the FSN and schedule a time to perform the software update.

  • Update the IFU with the supplement provided with the FSN or by Dräger’s service engineers at the time of software installation.

Action by

All those who use these devices.

Deadlines for actions

Actions underway: 1 March 2017

Actions complete: 15 March 2017

Problem / background

This error condition (referred to by Dräger as ‘Poti unplugged’) which could result in the ventilator stopping, is caused by an accumulation of an oxide layer in the potentiometer when these are rarely (or never) moved. The layer develops over time, but twisting the potentiometer knobs prevents this, as described in Dräger’s FSN that was sent to customers in 2015.

Dräger have now issued software which enables the ventilation to continue with the last, valid parameters (and posts the corresponding alarms). Additionally, the new software prompts turning of the potentiometer knobs in the pre-use device check, so the issue should not occur.

Manufacturer contacts

Dräger Quality Department

Tel: 01442 292 870

Email Helen.Glass@draeger.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:

  • A&E departments
  • Adult intensive care units
  • Ambulance staff
  • Anaesthetic medical staff
  • Biomedical engineering staff
  • EBME departments
  • Equipment stores
  • Equipment libraries and stores
  • Health and safety managers
  • Intensive care units
  • Medical physics departments
  • Paediatric intensive care units
  • Paediatric wards
  • Patient transport managers
  • Purchasing managers
  • Resuscitation officers and trainers
  • Risk managers
  • Special care baby units

Independent distribution

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

  • Hospitals in the independent sector

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/2017/001 or 2016/012/012/291/014.

Technical aspects

Hiten Patel or Emma Rooke, MHRA

Tel: 020 3080 6115 / 6609

Email: hiten.patel@mhra.gsi.gov.uk or emma.rooke@mhra.gsi.gov.uk.

Clinical aspects

MHRA Devices Clinical Team

Tel: 020 3080 6000 (Customer Services)

Email: DCT@mhra.gsi.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

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

Reporting adverse incidents in Northern Ireland

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 document

MDA/2017/001

Updates to this page

Published 8 February 2017
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