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Medical Device Alert: Harrier powered wheelchairs manufactured by Invacare (MDA/2009/064)

Document details:

Type: Medical Device Alert
Series No: MDA/2009/064
Audience: Healthcare professionals
Published: 15 October 2009 at 11:00
Format: Electronic only
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Action

Ref: MDA/2009/064 | Issued: 15 October 2009 at 11:00

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer contacts
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/064 or 2007/005/024/061/002.

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 (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 Jane Ludlow
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

Harrier powered wheelchairs manufactured by Invacare.
Models Plus, HD and XHD.

 

Harrier powered wheelchair manufactured by Invacare

This alert is specific to:

  • Harrier Plus wheelchairs manufactured before 15 May 2009 with a serial number lower than 07097844987
  • Harrier HD wheelchairs manufactured before 18 February 2009 with a serial number lower than 07097257918
  • Harrier XHD wheelchairs manufactured before 7 May 2009 with a serial number lower than 07097777051.

Harrier wheelchairs manufactured after these dates have been supplied with the revised instructions for use.

Invacare has revised the instructions for use for various safety aspects.

Users who are unaware of these new limitations are at risk of injury.

The MHRA has been made aware of a small number of reports relating to the safe use of the Harrier range of wheelchairs. Investigation revealed that various safety related aspects of the instructions for use (IFU) were incomplete or inaccurate.

The manufacturer has now updated the IFU including:

  • Reducing the maximum safe slope for both the Plus and XHD models to 6°.
  • Models fitted with tension adjustable upholstery are not suitable for use as a seat in transport.
  • The correct use and method of adjustment of the various types of lap belt supplied with this range of wheelchairs.
  • The intended life cycle for these wheelchairs has been added.

The updated IFU for all three Harrier models are available from Invacare UK or can be downloaded from the Invacare website (external link).

Invacare issued a Field Safety Notice in June 2009 (FSN019) but has been unable to trace all wheelchairs, particularly where they have been passed on to second or subsequent users.

  • Trace affected wheelchairs.
  • Ensure users are made aware of the revised instructions for use.
  • For all models fitted with a tension adjustable backrest, remove the tie-down labels from the frame.
  • Review the prescription of users affected by the revised instructions for use.

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 (Directors of Children’s Services)
  • Primary care trusts in England (Chief Executives)
  • Social services in England (Directors)

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:

  • Consultants in rehabilitation medicine or special seating
  • Equipment store managers
  • Health and safety managers
  • Maintenance staff and contractors
  • Occupational therapists
  • Patient transport managers
  • Physiotherapists
  • Rehabilitation engineers
  • Risk managers
  • Wheelchair and seating service 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)
  • Further education colleges registered as care homes
  • Hospices
  • Hospitals in the independent sector

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

  • Educational establishments with facilities for wheelchair users
  • Residential special schools
  • School transport managers

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

  • Community hospitals
  • Equipment store managers
  • Maintenance staff and contractors
  • Occupational therapists
  • Patient transport managers
  • Physiotherapists
  • Rehabilitation engineers
  • Risk managers
  • Wheelchair and seating service managers

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

  • Day centres
  • Equipment store managers
  • Maintenance staff and contractors
  • Occupational therapists
  • Transport managers for wheelchair users
  • Wheelchair and seating service managers

Technical Services Department
Invacare UK Operations Ltd
South Road
Bridgend Industrial Estate
Bridgend
CF31 3PY

Tel: 01656 647 327
Fax: 01656 753 299

Email: UK@invacare.com

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk
Page last modified: 15 October 2009