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MDA/2007/080 - EMS ventilator circuits, product code W196-002 manufactured by Galemed Corporation

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/080
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 24 October 2007 at 14:00
Ref: MDA/2007/080

 

Tick mark
Immediate action
 
Action
 
Update
Tick mark
Information request

 

Device:
EMS ventilator circuits, product code W196-002 manufactured by Galemed Corporation and supplied by Smiths Medical. These are breathing systems for use with Smiths Medical emergency and transport ventilators including: Parapac, Ventipac, Rescupac and Transpac models.

>Page 2

Problem:
A manufacturing problem has been identified where the valve in these breathing systems will not open, resulting in a blockage and potentially no oxygen being delivered to the patient.
Galemed Corporation believes that this issue only affects three lot numbers of EMS ventilator circuits. These lot numbers are: 070528, 070620 and 070910.

>Page 2

Action by:
All those using the Parapac, Ventipac, Rescupac and Transpac models of ventilator.		  

Action:

  1. Locate and quarantine EMS ventilator circuits of lot numbers 070528, 070620 and 070910.
  2. Contact Smiths Medical to arrange disposal and replacement of any affected devices.
  3. If replacement breathing systems are not available then ensure alternative ventilators and their breathing systems are available.
  4. If no alternative ventilators and breathing systems are available then:
    • Hospital trusts should ensure that pre-use checks are undertaken for all EMS ventilator circuits (appendix).
    • Ambulance trusts should check ambulance stock immediately and further stock should be checked before being placed on the vehicle (appendix).
  6. Ensure an alternative oxygen supply and means of ventilation are always available when using any ventilator e.g. a self-inflating bag and oxygen cylinder.
  7. Inform the MHRA of any further similar incidents that occur involving the EMS ventilator circuits.
  

Distributed to:

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

* via CE Bulletin

>Page 2

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

>Pages 2-3

Appendix:
Pre-use checks from the instructions for use.		  >Pages 4-5


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 31 October 2007
Deadline (action complete): 14 November 2007

Page last modified: 24 October 2007