Medical Device Alert: Oxford Voyager fixed ceiling hoist system fitted with X-Y gate system manufactured by BHM Medical, supplied by Sunrise Medical or Joerns Healthcare (MDA/2011/020)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/020 or 2009/010/012/261/001.

Brian Mather or Graham Sandwell
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
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

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

Due to insufficient information in the installation, inspection and maintenance instructions this hoist may detach from the track during use. This would result in serious injury to the occupant or others.

Joerns Healthcare issued a Field Safety Notice (dated 17 September 2010) incorporating revised instructions but has been unable to trace all users.

• Locate all affected hoists.
• Obtain a copy of the Field Safety Notice containing the revised installation, inspection and maintenance instructions.
• Arrange for the gate system to be inspected in accordance with the revised instructions.
• Gate systems that cannot be set up in accordance with the revised instructions should be removed from use until repaired/replaced.
• Ensure that procedures are in place for regular inspection and maintenance in accordance with the revised instructions.

This MDA has been sent to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Equipment Co-ordinators)
• 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 relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• All wards
• Back care/manual handling advisers
• Equipment store managers
• Estates departments
• Health and safety managers
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Nurses
• Nursing executive directors
• Occupational therapists
• Physiotherapists
• Risk managers

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

• Back care/manual handling advisers
• Community hospitals
• District nurses
• Equipment store managers
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Occupational therapists
• Physiotherapists
• Risk managers
• Social services

Liaison officers for onward distribution to all relevant staff including:

• Back care/manual handling advisers
• Care at home staff
• Care management team managers
• Community care staff
• Day centres
• Equipment store managers
• In-house residential care homes
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Occupational therapists
• Palliative care teams
• Risk managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• 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

Establishments registered with OFSTED
This alert should be read by:

• Educational establishments with hoists
• Residential special schools

Customer Services
Joerns Healthcare
Limited High Street, Wollaston, Stourbridge
West Midlands
DY8 4PS

Tel: 01384 446 622
Fax: 01384 446 601

Email: info@joerns.co.uk 

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