Medical Device Alert: Appollo bath hoists manufactured by Reva Industries Ltd (MDA/2010/051)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/051 or 2008/011/013/301/002.

Ed Ball or James McVeigh
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

There is a risk of the occupant sliding out of the seat and sustaining serious injury.

Reva Industries Limited issued a Field Safety Notice in March 2010 calling for all their bath hoists to be retrospectively fitted with a safety belt. Reva Industries Limited subsequently redesigned the seat assembly with a repositioned safety belt mounting, intended to further reduce the risk of the occupant falling from the bath hoist seat during use. Reva Industries intends that the assembly will be fitted to all new bath hoists from the end of July 2010.

The Reva Industries redesigned seat assembly and belt also fit Appollo bath hoists previously manufactured by Aquabeau and Airbath Appollo due to the similarity in design. Reva Industries is willing to supply these assemblies for retrofitting to these bath hoists, but there will be a charge.

• Trace all Appollo bath hoists.
• Contact Reva Industries Ltd to arrange supply of a replacement seat and belt assembly, complete with instructions on installation and use.
• Ensure the new assembly and belt are fitted and that all users are aware of the instructions for use.

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)
• Social services 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:

• All wards
• Equipment store managers
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Nurses
• Nursing executive 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
• Nursing agencies

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 co-ordinators
• Nurses
• Occupational therapists
• Palliative care team
• Physiotherapists
• Risk managers

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

• Care at home staff
• Care management team managers
• Equipment store managers
• In-house domiciliary care providers (personal care services in the home)
• In-house residential care homes
• Moving and handling co-ordinators
• Occupational therapists

Reva Industries
Rotterdam Road
Sutton Fields Industrial Estate
Hull
HU7 0XD

Tel: 01482 373813
Fax: 01482 585273