Medical Device Alert: Alvema ITO pushchair for disabled children manufactured by Eurovema AB and supplied in the UK by Rainbow Mobility Ltd (MDA/2010/057)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/057 or 2010/001/005/081/002.

David Small or Brian Mather
Medicines and 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
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

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 3922

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

The frame tubes can break causing the pushchair to tip and injure the occupant or carer.

Eurovema AB has issued a Field Safety Notice (FSN) but is unable to trace all the affected pushchairs.

The MHRA is aware of several instances where frequent use of the foot-brake over time causes an elongation of the mounting holes in the rear vertical frame tubes. This can lead to fracture of the frame at the brake attachment point. There have also been instances of the front frame fracturing at the castor assembly connection point.

The manufacturer has agreed to replace all affected frames with a strengthened frame assembly.

• Trace all affected ITO pushchairs
• Contact Rainbow Mobility Ltd to arrange for a replacement frame to be supplied and fitted free of charge.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• 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:

• Equipment store Managers
• Health and safety managers
• Maintenance staff and contractors
• Occupational therapists
• Paediatric departments
• Physiotherapists
• Rehabilitation engineers
• Risk managers
• Wheelchair and seating service managers

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

• Educational establishments with facilities for wheelchair users
• Residential special schools

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

• Community children’s nurses
• Equipment store managers
• Maintenance staff and contractors
• Occupational therapists
• Physiotherapists
• Risk managers
• Wheelchair and seating service managers

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

• Children’s disability services
• Equipment store managers
• Maintenance staff and contractors
• Occupational therapists
• Risk managers
• Wheelchair and seating service managers

Rainbow Mobility Ltd
Mill Lane
Ness
Cheshire
CH64 8TP

Tel: 0151 353 1234
Fax: 0151 336 3652

Email: brian.young@rainbowmobility.com