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Liko FreeSpan Traverse & FreeSpan Ultra Twin Traverse Freestanding Lift Systems
Notice type:
Advisory
Date:
25/02/2014
Product name or type:
Liko FreeSpan Traverse & FreeSpan Ultra Twin Traverse Freestanding Lift Systems
Reference:
SN2014(07)
Manufacturer Or Supplier:
Liko / Hill-Rom
Target Audience:
General Public
Hospital CEOs
Risk Managers
Procurement Managers
Loan Store Managers
Clinical Engineers
HSE Offices
Community Care Centres
Occupational Therapists
Community Care Managers
Community Therapists
Health Visitors
Carers
Educational Establishments
Problem Or Issue:
Hill-Rom has identified that information in the instructions guide dated the 7th November 2007 and earlier for the FreeSpan Traverse & FreeSpan Ultra Twin Traverse Freestanding Lift Systems is not clear regarding maximum overhang allowed for the systems.
Background Information Or Related Documents:
Hill-Rom is informing users that when assembled, the system is not designed to have an overhang greater than 300mm (11.8 inches). If the overhang is greater than 300mm (11.8 inches), there is a risk for the system to tip over. This information was not clear in the instructions (3EN110750-01 thru - 04) shipped prior to the 7th November 2007. Systems sold after the 7th November 2007 are not affected by this issue.
This field safety corrective action has been ongoing since July 2012. Hill-Rom has been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. There are four affected lifting systems on the Irish market, which cannot be located. These products were supplied to the Irish market by KCI Medical, who are no longer a distributor for these products.
The IMB has not received any complaints in relation to this issue. Full details of the field safety corrective action can be found in the attached field safety notice issued by Hill-Rom.
Liko FreeSpan TraverseFreeSpan Ultra Twin Traverse Freestanding Lift Systems Document
Actions To Be Taken:
The IMB advises that users:
(1) The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation, including those who maintain lifting systems and to any other persons/organisations where these devices have been transferred.
(2) Identify the location of all affected lifting systems.
(3) If you / your institution have any affected lifting systems, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and examine the set-up of the lifting system.
Further Information:
Enquries:
Enquiries to the manufacturer should be addressed to:
Marlene Bjurman
Hill-Rom Liko Luleå
Nedre Vägen 100
97592 Luleå
Sweden
Telephone: +46-920-47-47-00
Fax: +46-920-47-47-01
Email:
se.quality@hill-rom.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 copy of the field safety notice
Please click here to view a PDF version of the safety notice
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Date Printed: 27/04/2024