Medical Device Alert: Arjo Passive Clip sling and Arjo Passive Clip Flite slings manufactured by Medibo (MDA/2010/013)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/013 or 2009/010/019/081/013.

John Ward
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3232
Fax: 020 7084 3209

Email: john.ward@mhra.gsi.gov.uk

Maurice Rand
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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

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 3505 / 3922

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

Incorrect attachment of the sling clips to the spreader bar. This can lead to the person in the sling falling out and injuring themselves or others.

A number of incidents have occurred where the sling clip has not been fitted correctly before hoisting the occupant.

The manufacturer issued a Field Safety Notice in October 2009 but has been unable to trace all existing users.

The revised instructions for use and labelling for slings put particular emphasis on the correct fitting of the sling clips before the occupant is lifted (as shown above).

• If you did not receive the FSN contact Arjo Med AB Ltd to obtain updated instructions for use and new labels.
• Ensure users are aware of and follow the content of the revised instructions for use.
• Ensure that the new labels are attached to the hanger bar.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC) (headquarters)
• 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
• equipment store managers
• maintenance staff and contractors
• moving and handling coordinators
• 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 coordinators
• occupational therapists