Medical Device Alert: C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT) (MDA/2010/010)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/010 or 2009/006/003/291/015.

James McVeigh or Ed Ball
Medicines & Healthcare products Regulatory Agency
Centre for Assistive Technology
241 Bristol Avenue
Bispham
Blackpool
FY2 0BR

Tel: 01253 596 000
Fax: 01253 596 177

Email: bav@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:

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

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 3505 / 3922

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

There is a risk of injury to the attendant’s hand, by the climbing mechanism, if the stair climber is activated when two people are moving it.

The MHRA was made aware of an incident in which an attendant was injured whilst the (unoccupied) stair climber was being handled by two people. One attendant’s thumb was trapped against the lower frame tube by the climbing mechanism.

As a result of this incident the manufacturer has:

• added a protective guard
• revised their instructions for use providing new information on moving and handling.

AAT issued a Field Safety Notice in October 2009 but have been unable to trace all existing stair climbers.

1. Trace all affected stair climbers.

2. Contact AAT to arrange for a protective cover to be fitted around the mechanism and to obtain a copy of the revised instructions for use.

3. Ensure that all operators and attendants are aware of these revised instructions for use.

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)
• OFSTED
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)

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:

• Ambulance services directors
• Ambulance staff
• Equipment store managers
• Maintenance staff and contractors
• Moving and handling coordinators
• Patient transport managers
• Risk managers

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

• Care homes providing nursing care (adults)
• Care homes providing personal care (adults)
• Hospitals in the independent sector

OFSTED to:
The MHRA considers this to be important to:

• Residential special schools
• Schools with facilities for the disabled

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Community hospitals
• Equipment store managers
• Maintenance staff and contractors
• Moving and handling coordinators
• Patient transport managers

Social services to:
Liaison officers for onward distribution to all relevant staff including:

• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
• Equipment store managers
• In-house residential care homes
• Loan store managers
• Moving and handling coordinators
• Transport managers

Supplier:
Mr C Singh
AAT (GB) Ltd
Unit 6, Miners Road
Llay Industrial Estate
Llay
Wrexham
LL12 0JP

Tel: 01978 853 900
Fax: 01978 853 930

Email: c.singh@aatgb.com

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk