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MDA/2007/002 - Device: Patient monitoring system - Philips Medical Systems Multi-Measurement Server (MMS) Model: M3001A and SpO2 Module M1020B

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/002
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 9
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 08 January 2007 at 14:30
Ref: MDA/2007/002

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Device: Patient monitoring system - Philips Medical Systems Multi-Measurement Server (MMS) Model: M3001A and SpO2 Module M1020B.

>Page 2

Problem:
The pulse oximeter channel of the MMS or the SpO2 module in these monitors when used with disposable SpO2 transducers/probes may display a 100% saturation when the transducer is not attached to a patient. Should this happen in the case of a hypoxic patient, no alarm will be given.

>Page 2

Action by:
Anaesthetists, operating theatre practitioners, intensive care, A&E, ambulance and technical staff.		  

Action:

  • Ensure you have received the urgent device correction notice from Philips (see appendix in pdf only).
  • Identify suspect devices (as described in the appended letter in pdf only) and contact Philips to either request a software upgrade or to confirm that you will be upgrading the equipment yourself.
  • Follow the advice at the end of the appended letter regarding their continued use until the upgrade is complete (procedure to mitigate the risk).
  

Distributed to:

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

* 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 3

Appendix:
Philips device correction notice (in pdf only).

>Pages 4-9



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 08 February 2007
Deadline (action complete): 08 March 2007


Page last modified: 07 February 2008