Notice Information: - Advisory - 06/09/2012

Title:

ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with Passive Clip Slings and Clip Flite Slings

Product:

ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with Passive Clip Slings and Clip Flite Slings

Reference:

SN2012(15)

Manufacturer / Supplier:

ArjoHuntleigh / Medibo

Target Audience:

General public
Hospital CEOs
Risk Managers
Procurement Managers
Loan Store Managers
HSE Offices
Community Care Centres
Occupational Therapists
Community Care Managers
Community Therapists
Health Visitors
Carers
Educational Establishments

Issue:

ArjoHuntleigh’s complaint trending has shown a number of events relating to clip detachments. Analysis and investigation of the root cause of these reported events has shown that non-attachment or incorrect attachment of the clip has been a main cause of what has been perceived as detachments. If the sling clips are not applied or are not applied correctly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.

ArjoHuntleigh have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. This alert applies to any users of ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts on the Irish market that have not previously carried out this recommended action.

Background Information / Related Documents:

ArjoHuntleigh developed a labelling package in order to help ensure proper application of the sling clips to the hanger bar attachment lugs. This action affects all the ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings distributed before June 2009.

All relevant information relating to this field action can be found in the attached field safety notice, issued by ArjoHuntleigh in June 2009.

Action to be taken:

The IMB advises that users:

1. Ensure the appropriate personnel are made aware of this notice.

2. Identify the location of all affected lifts.

3. If you / your institution have affected lifts, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.

Further Information:

Enquiries to the manufacturer should be addressed to:

Rachel Dempster
ArjoHuntleigh (Ireland) Limited
EA House
Damastown Industrial Park
Mulhuddart
Dublin 15

Telephone: +353 (0)1 809 8960
Fax: +353 (0)1 809 8971
Email: Compliancealie@arjohuntleigh.com

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

Irish Medicines Board
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.imb.ie

Please click here to view a PDF version of this Safety Notice

Please click here to view a copy of the Field Safety Notice