Medical Device Alert: Handle assembly fitted to monkey pole manufactured by Rolko GmbH and supplied in the UK by Hill-Rom (MDA/2010/045)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/045 or 2010/001/005/291/006.

Technical aspects
Brian Mather or David Small
Medicines and Healthcare products Regulatory Agency
Centre for Assistive Technology
241 Bristol Avenue
Bispham
Blackpool
FY2 0BR

Tel: 01253 596000
Fax: 01253 596177

Email: bav@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@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 height adjuster can fail in use, resulting in the strap extending and the handle dropping. This may cause the patient to fall and sustain an injury.

Hill-Rom has issued a Field Safety Notice but has been unable to trace all affected handle assemblies.

• Remove affected handle assemblies from use.
• Contact Hill-Rom to obtain, free of charge, replacement handle assemblies, complete with fitting instructions, quoting reference MOD426.

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:

• All wards
• EBME department managers
• Equipment store managers
• Hospital at home units
• Maintenance staff and contractors
• Nurses
• Nursing directors
• Occupational therapists
• Physiotherapists
• 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)
• Domiciliary care providers
• Further education colleges registered as care homes
• Hospices
• Hospitals in the independent sector

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

• Educational establishments with beds for children
• Residential special schools

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

• Community hospitals
• Loan store managers
• Maintenance staff and contractors
• Nurses
• Occupational therapists
• Physiotherapists

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

• Care at home staff
• Care management team managers
• Community care staff
• In-house domiciliary care providers (personal care services in the home)
• In-house residential care homes
• Loan store managers
• Maintenance staff and contractors
• Occupational therapists

Hill-Rom Technical Support
Clinitron House
Ashby Park
Ashby de la Zouch
LE65 1JG

Tel: 01530 411 000
Fax: 01530 562 029

Email: uk.customer.care@hill-rom.com