Medical Device Alert: Servo 300 ventilator (SV300) manufactured by Siemens (now Maquet) (MDA/2009/042)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/042 or 2009/003/031/061/006.

Technical aspects
Louise Mulroy or Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3344/3219
Fax: 020 7084 3209
E-mail: louise.mulroy@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Tom Clutton-Brock
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3056
Fax: 020 7084 3111
E-mail: tom.clutton-brock@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900
E-mail: NIAIC@dhsspsni.gov.uk

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic
Further information about SABS can be found at https://sabs.dhsspsni.gov.uk

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

E-mail: iric.nss@nhs.net

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

E-mail: Haz-Aic@wales.gsi.gov.uk

The expiration valve may fail to close, leading to a risk of hypoxia if corresponding ventilator alarms are ignored.

The expiratory valve of the SV300 regulates the positive end expiratory pressure (PEEP) during expiration and it closes during inspiration. This valve is controlled by two printed circuit boards (PC1585/PC1586) and if these stop working, the expiratory valve stays in the open position.

During 2007 and 2008, Maquet noted a 0.36% world wide failure rate of the circuit boards. In the UK, there was one report of this issue in 2004, with a device that was over eight years old. Maquet’s investigation has shown that the main reason for this problem is age-induced wear of components in the circuit boards.

If the circuit boards fail, the ventilator will still allow expiration and spontaneous breathing through the ventilator. However, during inspiration the gas flow will not ventilate the patient, but instead escape through the open expiratory valve. When the circuit boards fail, a low minute volume alarm and sometimes an upper pressure alarm will be generated if the measurements are outside user set limits. If the patient is not attended to when the alarms are triggered, there may be serious consequences (hypoventilation or hypoxia). However, this failure has not caused any patient injury to date.

Maquet issued a Field Safety Notice in April 2009 to advise users on how to rectify this problem. This Medical Device Alert has been issued due to the widespread use of the devices and poor response rate to Maquet’s Field Safety Notice. Maquet expects the upgrade to all ventilators in the UK to be completed by the end of September 2009.

Maintenance and service staff

• Identify all Servo 300 ventilators.
• Ensure installation of a 3,000 hour kit with redesigned part at the next service (either 1,000 hrs/6 months or 3,000 hrs/12 months).
• Contact Maquet if installation of circuit board is not done by end of September 2009.

Intensive care staff to

• Be aware of Maquet’s Field Safety Notice.
• Ensure that the lower minute volume alarm limit and upper pressure limit are set according to the operating instructions.
• Adhere to the advice provided in the ‘Important’ section of the operating instructions.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Intensive care units (adult and paediatric)
• Anaesthetists
• Clinical governance leads
• EBME departments
• Health and safety managers
• In-house maintenance staff
• Intensive care, directors of
• Intensive care medical staff and nursing staff (adult and paediatric)
• Medical directors
• Medical equipment libraries
• Medical physics departments
• Nursing executive directors
• Neonatology directors
• Risk managers
• Special care baby units
• Theatre managers
• Theatres

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Hospitals in the independent sector

Change of address or removal from address list for Care Quality Commission:
National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61
E-mail: enquiries@cqc.org.uk

Colin Moralee
Maquet Ltd
14-15 Burford Way
Boldon Business Park
Sunderland
NE35 9PZ

Tel: 0191 519 6200
Fax: 0191 519 6201
E-mail: cmoralee@maquet.co.uk