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Mini Lift Stand Aid

Notice type: Warning

Date: 27/07/2007

  

Product name or type:
Mini Lift Stand Aid

Reference:
SN2007(04)

Manufacturer Or Supplier:
Kjaerulff Rehabilitation A/S, Denmark / Beechfield Healthcare, Dublin

Target Audience:
Hospital Chief Executive Officers; Hospital Risk Managers; Health Service Executive; Nursing Executive Directors; Occupational Therapists; Physiotherapists; Nursing Home Managers

Problem Or Issue:
Brass bolt connecting the lift arm to the lifting actuator may fail if bolt wear is overlooked during recommended annual inspections.

Background Information Or Related Documents:
Following two separate incidents in the United Kingdom in September 2006, in which the bolt that connects the lifting arm to the lifting actuator failed due to wear and tear of the brass pin, the manufacturer has distributed service instructions and replacement steel bolts to all affected customers.  Customers are asked to perform an immediate service check and replace the brass bolts with the steel bolts regardless of their condition.  Although there have been no reports of failure of the brass pin connecting the lower frame to the actuator customers are also being asked to replace these as an added safety precaution.  Affected article numbers which require bolt replacement are 400600434 and 400605434.  Mini lifts with article number 400640434 supplied after March 2006 are not affected by this issue as they are equipped with the steel bolts.

Mini Lift Stand Aid Document

Actions To Be Taken:
  • Advise Kjaerulff Rehabilitation A/S - Handicare A/S of the number and location of all affected devices in your institution.
  • Ensure the modification is carried out on all affected devices. 

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

Health Products Regulatory Authority
Medical Devices Department 
Kevin O'Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   
Telephone:     +353-1-6764971 
Fax:               +353-1-6344033 
Email:             vigilance@imb.ie
Website:         www.hpra.ie   

Enquiries to the manufacturer should be addressed to:   
Mr. Philip L. Harris 
Kjaerulff Rehabilitation A/S - Handicare A/S 
Ørkebyvej 6 
DK-5450 Otterup 
Denmark   

Telephone:      +45-6382-1532 
Fax:                +45-6482-1449 
Email:              plh@kjaerulff.com

SN2007(04): Mini Lift Stand Aid

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