In Safety warnings

Enter a keyword or phrase to search all pages in this section:


Advanced search

Archive:

Looking for a previously published document in this section?

MDA/2007/014 - Fisher and Paykel Healthcare re-usable CPAP respiratory masks and connectors for obstructive sleep apnoea

Printer friendly version (new window)

Document details:

Type: Medical Device Alert
Series No: MDA/2007/014
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

Page 1

Issued: 07 February 2007 at 15:00
Ref: MDA/2007/014

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Fisher and Paykel Healthcare re-usable CPAP respiratory masks and connectors for obstructive sleep apnoea.		  
Problem:
Plastic tabs incorporated into the re-usable CPAP mask connectors may break off when in use with the possibility of components entering the patient’s airways. The affected connectors are found in most Fisher and Paykel CPAP face, nasal and oral mask kits, and various tubing kits. Fisher and Paykel have now redesigned this connector (available since April 2006) and are recalling all face mask kits with the previous version; the recall notice and fax back form are appended to this alert (in pdf only).		  
Action by:
All those involved in the purchase and use of these devices.		  

Action:

  • Ensure all relevant staff are aware of this recall; customer letter and recall fax back form are appended to this alert.
  • Identify devices currently in use and arrange for alternatives to be provided.
  • Identify and remove all unused affected stock.
  • Contact the manufacturer to arrange collection and replacement of stock.
  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

>Page 2

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

>Page 2

Appendix:
Manufacturer's customer letter and recall fax back form (in pdf only).

>Pages 4-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 23 February 2007
Deadline (action complete): 16 March 2007

Page last modified: 07 February 2008