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MDA/2006/060 - Wheelchair backs - Sunrise Medical Jay® J2

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/060
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 8
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 19 October 2006 at 11:00
Ref: MDA/2006/060


 
Immediate action
Tick mark
Action
 
Update
 
Information request


This alert supersedes MDA/2006/056 which has been withdrawn.
The actions in the previous alert included an incorrect angle of recline.

Device:
Wheelchair backs - Sunrise Medical Jay® J2.		  
Problem:
The manufacturer's original instructions for use (IFU) did not give sufficient detail to allow the devices to be fitted, used and maintained safely, thus putting the users of the backs at risk of serious injury.

>Page 2

Action by:
All those involved with the prescription, provision and maintenance of these wheelchair backs.

>Page 2

Action:

  • Withdraw MDA/2006/056 and issue this alert to replace it. The Appendix is unchanged.
  • Identify all Sunrise Medical Jay® J2 backs already in use.
  • Provide a copy of the latest IFU to all current users so that they are aware of the revised limitations in use as specified by the manufacturer.
  • Provide a copy of the latest maintenance information to users and maintenance providers
  • Review all existing users for alternative backrests where users have Jay® J2 backs fitted to wheelchairs with seating that tilts in space more than 60° from the vertical or backs that recline more than 60° from the vertical or who use Jay® J2 backs whilst seated in their wheelchairs in motor vehicles.

>Pages 5-8

>Page 2

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
Social services in England - Directors*

* via CE Bulletin

>Pages 2-3

Contacts:
Details of manufacturer/supplier contacts and MHRA contacts.
Change of address or removal from address list for CSCI and Healthcare Commission.

>Page 3

Appendix:
Jay® J2 backs instructions for use. (pdf only)

>Pages 5-8



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 17 November 2006
Deadline (action complete): 19 January 2007
Note to SABS Liaison Officers:
In order to close electronic response form for MDA/2006/056, select "No action is required", indicating "Alert superseded by MDA/2006/060" in the action text box.


Page last modified: 07 February 2008