Wheeled and non-wheeled walking frames (all models) - potential for detachment of the wheels and/or inadequately tightened screws
(Patterson Medical) May cause the user to fall. (MDA/2013/060)
CAS deadlines
Action underway: 2 September 2013, action complete: 1 November 2013
Note: These deadlines are for affected frames to be identified and systems put in place to carry out the checks.
Device
Wheeled and non-wheeled walking frames (all models).
Manufactured by Patterson Medical.
Batch codes from DMW12013 to DMW82013 inclusive.
Note - paediatric walking frames manufactured by Patterson Medical are not affected.
Problem
Potential for detachment of the wheels and/or inadequately tightened screws, which may cause the user to fall.
Frames of specific batches produced from January 2013 to March 2013 may not have been manufactured to specification.
The manufacturer issued a
(158Kb) in May 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information.Action
Ensure that those responsible for provision and maintenance of these devices:
- identify affected devices
- perform the checks and actions detailed in the manufacturer’s (158Kb)
- complete the reply letter and return it to Patterson Medical.
Action by
All those involved in the provision and maintenance of these devices.
Distribution
This MDA has been sent to:
- Care Quality Commission (CQC) (headquarters) for information
- Clinical commissioning groups (CCGs)
- Health and Safety Executive
- HSC trusts in Northern Ireland (chief executives)
- Local authorities in Scotland (equipment coordinators)
- NHS boards and trusts in Wales (chief executives)
- NHS boards in Scotland (equipment coordinators)
- NHS England area teams for information
- NHS 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:
- Community hospitals
- Community nurses
- Equipment libraries and stores
- Equipment stores
- In-house maintenance staff
- Maintenance staff
- Occupational therapists
- Physiotherapists
- Rehabilitation engineers
Social services
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team managers
- Community care staff
- Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
- Disability equipment stores
- Equipment stores
- Equipment supplies managers
- In-house domiciliary care providers (personal care services in the home)
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
- Occupational therapists
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- Adult placement
- 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
- Independent treatment centres
- Nursing agencies
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.
Manufacturer contact
Manufacturer
Patterson Medical
Customer Services
North Road
Bridgend Industrial Estate
Bridgend
Wales, CF31 3TP
Tel: 0844 412 4330
Fax: 0844 873 0100
Email: retail.sales@pattersonmedical.com
Feedback
If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk.
England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/060 or 2013/005/029/601/007
Technical aspects
Emma Rooke and Elke Kerwick
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 6609/6826
Fax: 020 8754 3965
Email: emma.rooke@mhra.gsi.gov.uk or elke.kerwick@mhra.gsi.gov.uk
Clinical aspects
Jonathan Plumb
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 6648
Fax: 020 8754 3965
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 CAS website
Northern Ireland
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
How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website
Scotland
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
Wales
Enquiries in Wales should be addressed to:
Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk
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