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|Type:||Medical Device Alert|
|Published:||15 October 2009 at 11:00|
Ref: MDA/2009/064 | Issued: 15 October 2009 at 11:00
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
Tel: 01253 596 000
Fax: 01253 596 177
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)
Estate Policy Directorate
Tel: 02890 523 704
Fax: 02890 523 900
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
1 South Gyle Crescent
Tel: 0131 275 7575
Fax: 0131 314 0722
Enquiries in Wales should be addressed to:
Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Tel: 029 2082 3505 / 3922
Harrier powered wheelchairs manufactured by Invacare.
Models Plus, HD and XHD.
This alert is specific to:
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:
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.
This MDA has been distributed to:
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:
The MHRA considers this to be important to:
Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:
Social services to:
Liaison officers for onward distribution to all relevant staff including:
Technical Services Department
Invacare UK Operations Ltd
Bridgend Industrial Estate
Tel: 01656 647 327
Fax: 01656 753 299