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| Type: | Medical Device Alert |
|---|---|
| Series No: | MDA/2010/022 |
| Audience: | Healthcare professionals |
| Published: | 10 March 2010 at 15:00 |
| Format: | Electronic only |
| Size: | A4 |
| Pages: | 5 |
| Price: | Free |
| ISBN/ISSN: | |
| 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/2010/022 | Issued: 10 March 2010 at 15:00
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/022 or 2010/002/004/601/001.
John Ward
Medicines and 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 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 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
Hoists and standing aids.
Models: Cricket-3, Cypress-2, Ergolift, Ergolift 600, Ergostand, Explorer, Explorer 600, Graduate, Junior, Medilifter-IV, Mezzo, Ministand, ML-4, Primo, Sherpa, SSL-2, Standup, Trekker and Xtreme.
Manufactured by BHM Medical Inc.
The manufacturer has determined that hoists manufactured from May 2004 to March 2006 inclusive may have been fitted incorrectly with a single insulated power cable. Unfortunately, no serial numbers are available to assist identification of the various models.
Risk of electric shock when the hoist is connected to the mains supply with a single insulated power cable for battery charging.
An incident occurred where the single insulated cable was damaged during use and the hoist structure subsequently became ‘live’ when the hoist was connected to the mains supply for battery recharging. The manufacturer is contacting local distributors in the UK, but has so far not been able to reach end users.
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:
Paul Lovell
Huntleigh Healthcare Ltd
310-312 Dallow Road
Luton
Bedfordshire
LU1 1TD
Tel: 01582 745751
Fax: 01582 745725