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MDA/2007/017 - External defibrillator: Welch Allyn, model PIC 50

Document details:

Type: Medical Device Alert
Series No: MDA/2007/017
Audience: Healthcare Professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 14 February 2007 at 10:30
Ref: MDA/2007/017
 

 
Immediate action
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Action
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Update
 
Information request




Device:
External defibrillator: Welch Allyn, model PIC 50.

>Page 2

Problem:
Failure to defibrillate. The manufacturer is recalling PIC 50 defibrillators to correct TWO malfunctions that prevent or delay the delivery of therapy, which can lead to failure to resuscitate a patient.

One of these malfunctions was the subject of an ongoing recall covered by MDA/2006/047, issued in August 2006. This alert updates the recommendations made in that alert.

 
Action by:
All medical, nursing and paramedical staff, resuscitation training officers, community defibrillation officers and technical staff responsible for the use, maintenance and purchase of these devices.

>Page 2

Action:
Identify affected devices using the lists shown in the Appendix.

  • Contact the manufacturer to arrange service and upgrade as soon as possible.
  • Consider if it is appropriate to substitute alternative defibrillators for those affected devices that are in service but are awaiting upgrade.
  • If affected devices awaiting upgrade are used and display either a ‘Defib Comm’ or ‘ECG Comm’ error message, the manufacturer has advised that switching the device off and then on again may clear the error message.
 

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 CSCI and Healthcare Commission.

>Page 3

Appendix:
Lists of PIC 50 defibrillator serial numbers located in the UK that are affected by the ‘Defib Comm’ recall, the ‘ECG Comm’ recall and those affected by both recalls.

>Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway):  07 March 2007
Deadline (action complete): 28 March 2007


 

Page last modified: 20 February 2007