Medical Device Alert: Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet) (MDA/2010/011)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/011 or 2009/007/031/401/015.

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

Tel: 020 7084 3193 / 3344
Fax: 020 7084 3209

Email: douglas.mcivor@mhra.gsi.gov.uk or louise.mulroy@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

Email: tom.clutton-brock@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

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

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).

Further information about SABS can be found on the SABS website (external link).

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

Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Excessive negative pressures (eg using closed suction systems) can damage the inspiratory and expiratory pressure measurement transducers. Such damage has lead to high gas flows that subsequently caused bilateral pneumothoraces.

The manufacturer has now confirmed that the transducers were damaged by excessive negative pressures, which may be related to the use of closed suction systems. These transducers were of an older design, which is susceptible to negative pressure damage. If upgraded transducers are required, they are available to purchase from Maquet.

In 2002 Siemens issued safety advice to upgrade the ventilators with a new design of pressure transducer, if users wished to use closed suction systems. Unfortunately the user manual was not updated at the time, therefore Maquet issued a Field Safety Notice in November 2009.

• Be aware of the manufacturer’s Field Safety Notice that updates the original user manual.
• Do not to use any system (eg closed suction systems) with the ventilator that may generate a negative pressure below -100 cm H2O, unless the ventilator has been fitted with the new modified pressure transducers.
• Before connecting the ventilator to the patient, always perform the manufacturer’s recommended pre-use checks.
• This MDA replaces MDA/2009/074.

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)
• NHS boards and trusts in Wales (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:

• anaesthetists
• clinical governance leads
• EBME departments
• health and safety managers
• in-house maintenance staff
• intensive care medical staff and nursing staff (adult, paediatric and neonatal)
• intensive care units (adult, paediatric and neonatal)
• medical directors
• medical equipment libraries
• Medical physics departments
• neonatologists
• nursing executive directors
• paediatricians
• risk managers
• special care baby units
• theatre managers

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• hospitals in the independent sector

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

Tel: 0191 519 6200
Fax: 0191 519 6201

Email: cmoralee@maquet.co.uk