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.
All those who use these devices
Deadlines for actions
Actions underway: 1 June 2017
Actions complete : 17 August 2017
Mr Michael Turvey
Philips Health Systems
Telephone: 0870 532 9741
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
- 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
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: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/012 or 2017/003/001/291/006.
Emma Rooke or Suleman Hussain, MHRA
Tel: 020 3080 6609/6956
Email: firstname.lastname@example.org or email@example.com
MHRA Devices Clinical Team
Telephone: 020 3080 7124
Reporting adverse incidents in England
Through Yellow Card
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
Telephone: 028 9052 3868
Northern Ireland Adverse Incident Centre (NIAIC)
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
Telephone: 0131 275 7575
Fax: 0131 314 0722
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).