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

Notice type: Advisory

Date: 06/09/2012

   

Product name or type:
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 Or 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 

Problem Or 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 Or 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. 

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

Actions 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: 

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

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

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