Medical Device Alert: Mobile hoists - Arjo Minstrel standard type and EPC type manufactured by Medibo Medical NV (MDA/2010/029)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/029 or 2009/011/003/401/001.

Jonathan Smith or Emma Rooke
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3600

Fax: 020 7084 6177

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).

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 

Inaccurate maintenance instructions and poor inspection of hanger bar attachment. Attachments have failed in use leading to a fall and injury to the person being moved.

There have been several incidents where the spreader bar has detached from the hoist boom due to failure of the attachment pivot bolt.

The bolt is welded to the hanger bar and cannot be serviced or replaced. The preventative maintenance schedule for the hanger bar, as detailed in the Minstrel operating and product care instructions (issue 4), is incorrect in requiring replacement of the bolt every three years by Arjo personnel. It should state that the complete spreader bar needs to be replaced every three years. The instructions also lack detail on the frequent checks required for the spreader bar attachment during the three year period.

Medibo Medical NV is updating its instructions and redesigning the hanger bar attachment but the new design is not yet available. Existing hoists require inspection to check if they are safe to use until the new design is available. Arjo has compiled a Field Safety Notice (FSN) giving detail of the inspection required by a competent person. However, this has not yet reached all users.

• Identify affected hoists by using the serial number list in the appendix.
• Remove the hoist from use and contact Arjo Med AB UK to arrange inspection and replacement of the hanger bar assembly.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC)
• 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)
• 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 coordinators
• 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

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

• Educational establishments with facilities for the disabled
• Residential special schools

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

• Community hospitals
• District nurses
• Equipment store managers
• Maintenance staff and contractors
• Moving and handling co-ordinators
• 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
• Community care staff
• Equipment store managers
• In-house domiciliary care providers (personal care services in the home)  
• In-house residential care homes
• Moving and handling coordinator
• Occupational specialists

Arjo Med AB Ltd
Customer Services

Tel: 07807 054713
Fax: 01452 428344

Email: uksales@arjo.co.uk

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