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BHM Medical Inc. Hoists

Notice type: Advisory

Date: 01/04/2011

  

Product name or type:
BHM Medical Inc. Hoists

Reference:
IMB Safety Notice: SN2011(04)

Manufacturer Or Supplier:
BHM Medical Inc.

Target Audience:
Health Board CEOs 
Community Care Managers 
Community Therapists 
Health Visitors 
Carers of the Elderly 
Risk Managers 
Loan Store Managers 
Children’s Disability Services 
Educational Establishments 
Theatre and Nursing Staff 
Procurement Managers 
Nursing Managers 
Clinical / Biomedical Engineers 

Problem Or Issue:
BHM Medical Inc. has become aware that a number of hoists may have been fitted with an incorrect power cable on the control box.

Background Information Or Related Documents:
BHM Medical Inc. has confirmed that a number of hoists manufactured from May 2004 to March 2006 inclusive may have been fitted incorrectly with a single insulated power cable which increases the risk of premature failure. A power cable failure may result in the hoist structure becoming live when the hoist is connected to the mains supply for battery charging and could expose the caregiver or patient to a risk of electrical shock. 

The following hoists are potentially be affected by this issue: 
• 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 
• Xtreme 

The manufacturer issued a field safety notice in February 2010 to advise users how to identify the affected cables. The affected cables are to be replaced with double insulated cables. 

BHM Medical Inc. Hoists Document

Actions To Be Taken:
The manufacturer and the distributors of this device in Ireland have been unsuccessful in their attempts to locate all hoists affected by this field safety corrective action (FSCA). 

The IMB advises that users: 
• Follow the manufacturer’s recommendations as outlined in the attached field safety notice. 
• Identify the affected hoists in your facility and contact the manufacturer to arrange for a power cable replacement. 
• Remove any affected devices from service pending installation of the new power cable. 

Further Information:
Enquiries to the manufacturer / European authorised representative should be addressed to: 

Mr. Paul Lovell 
Group Regulatory Approvals Manager 
ArjoHuntleigh 
310-312 Dallow Road 
Luton Bedfordshire 
LU1 1TD 
United Kingdom 

Tel: +44 (0)1582 745891 
Email: paul.lovell@huntleigh-technology.com

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: vigilance@imb.ie
Website: www.hpra.ie 

Please Click here to download a PDF Version of the Safety Notice

Please Click here to donwload Field Safety Notice

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