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| Type: | Medical Device Alert |
|---|---|
| Series No: | MDA/2010/018 |
| Audience: | Healthcare professionals |
| Published: | 9 March 2010 at 11:00 |
| Format: | Electronic only |
| Size: | A4 |
| Pages: | 4 |
| Price: | Free |
| ISBN/ISSN: | None |
| Author: | |
| Copyright: | Crown |
Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Ref: MDA/2010/018 | Issued: 9 March 2010 at 11:00
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/018 or 2009/007/022/401/003.
Jonathan Smith or Emma Rooke
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
Health Estates Investment Group
Room 17, Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ
Tel: 028 9052 3704
Fax: 028 9052 3900
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
All models of mobile hoists, ceiling hoists and bathing lifts manufactured by Joerns Healthcare Ltd.
Prior to 2007, when Joerns Healthcare Ltd took over manufacture of these hoists and lifts, they were manufactured by Oxford Ltd, Parker Baths Ltd and Sunrise Medical Ltd and may be labelled accordingly.
Lack of maintenance and inspection of these devices could lead to the occupant falling and being seriously injured.
The MHRA has received a small number of reports involving the detachment of spreader bars on Oxford hoists during use due to the hoists not being maintained in accordance with the manufacturer’s instructions. No serious injury has yet been reported but there is clearly the potential for this to occur.
The instructions for use (IFU) supplied by Joerns Healthcare state that the hoist must be maintained by an authorised service dealer on a six-monthly basis. Planned preventative maintenance (PPM) includes checks for wear on the spreader bar mounting and other moving parts.
Joerns Healthcare issued a Field Safety Notice (FSN) in November 2009 to remind all users and service providers of their responsibilities when using and maintaining any of their products. This FSN includes checks on the spreader bar to be carried out during PPM in addition to any inspections carried out under the Lifting Operations and Lifting Equipment Regulations (LOLER). However, the manufacturer cannot be sure that all relevant people received their FSN, so the MHRA has issued this alert.
The IFU are also available from the Joerns Healthcare website.
This MDA has been distributed to:
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:
Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:
OFSTED 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:
Customer Services Department
Joerns Healthcare Ltd
High Street
Wollaston
West Midlands
DY8 4PS
Tel: 01384 446 622
Fax: 01384 446 601
Email: info@joerns.co.uk