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MDA/2007/096 - Kimba Spring paediatric buggies manufactured by Otto Bock

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/096
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 10 December 2007 at 11:00
Ref: MDA/2007/096

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Kimba Spring paediatric buggies manufactured by Otto Bock.

>Page 2
Problem:
Risk of injury to the occupant due to frame failure and the seat suddenly tilting fully forwards or backwards.

>Page 2
Action by:
All those involved in the provision, prescription, repair, maintenance and use of these buggies. In particular wheelchair service managers, loan store managers, rehabilitation engineers, occupational therapists, paediatric services and wheelchair maintenance staff and contractors.		  

Action:

  • Trace all Kimba Spring paediatric buggies, in use or held in storage, which were supplied between April 2003 and April 2007 and inspect the seat tilt actuator frame mounting and surrounding area (see photographs in appendix - in pdf only).
  • Withdraw from service all those buggies showing signs of damage or cracks and contact Otto Bock for a replacement frame.
  • If no damage or cracks are found on the frame contact Otto Bock for the modification bracket and fitting instructions. Make arrangements to fit the new bracket.
  • Ensure that all users have the latest version of the Kimba Spring instructions for use (IFU), including the separate document detailing how it may be used as a seat in transport.
  

Distributed to:

NHS trusts in England - Chief Executives*
OFSTED - Directors of Children's Services
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
Social services in England - Directors*

* via CE Bulletin

>Page 2
Contacts:
Details of manufacturer contacts and MHRA contacts for technical aspects.
Change of address or removal from address list for Healthcare Commission.

>Page 3
Appendix:
Photographs of buggy with failure (in pdf only).

>Page 4


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 31 December 2007
Deadline (action complete): 28 February 2008


Page last modified: 07 February 2008