V60 ventilator – potential for unexpected shutdown

Manufactured by Philips Respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown

Action

  • Identify all devices with software version 2.20 (which may have been upgraded by some customers between 17 April 2016 and 4 January 2017) as per Philips’s FSN 86600036A.

  • Ensure either hospital biomedical engineers or Philips field service engineers install the correct software (version 2.10).

  • Philips advise in their FSN that devices with software version 2.20 should not be used unless close clinical observation is available.

  • If alternative devices are unavailable, carry out an individual risk assessment for the continued use of the devices with version 2.20 software until version 2.10 can be installed.

  • Contact Philips Respironics to acknowledge receipt of the FSN.

Action by

All those who use these devices

Deadlines for actions

Actions underway: 1 June 2017

Actions complete : 17 August 2017

Manufacturer contacts

Mr Michael Turvey
Q&R Officer
Philips Health Systems
Telephone: 0870 532 9741

Email: michael.turvey@philips.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
  • Anaesthetic medical staff
  • Anaesthetists
  • Biomedical engineering staff
  • Community hospitals
  • EBME departments
  • Equipment libraries and stores
  • General surgery
  • Health and safety managers
  • Intensive care units
  • Maintenance staff
  • Paediatric intensive care units
  • Respiratory units/wards
  • Resuscitation officers and trainers
  • Risk managers
  • Theatres

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/2017/012 or 2017/003/001/291/006.

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

MHRA Devices Clinical Team
Telephone: 020 3080 7124

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

Telephone: 028 9052 3868

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (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

Telephone: 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
Telephone: 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/2017/012

Published 17 May 2017