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Profile Respiratory System CR60 and Porta-Neb

Notice type: Advisory

Date: 14/03/2006

  

Product name or type:
Profile Respiratory System CR60 and Porta-Neb

Reference:
SN2006(02)

Manufacturer Or Supplier:
Respironics (UK) Limited / Oxygen Care Limited

Target Audience:
Health Board Chief Executives; Community Care Managers; Community Therapists; Health Visitors; Carers of the Elderly; Risk Managers; Loan Store Managers; Children's Disability Services; Special Schools; Educational Establishments

Problem Or Issue:
Incorrectly rated fuses in the IEC socket were fitted to the above devices manufactured between 4th March 2005 and 12th May 2005 due to a vendor issue.

Background Information Or Related Documents:

Above devices manufactured between 4th March 2005 and 12th May 2005.  The device may overheat and possibly fail if all of the following were to occur:   

  • There is a problem with the main supply
  • An incorrect mains lead is used
  • The internal thermal protection fails 
The manufacturer has undertaken corrective action of the affected product.  They have issued an advisory letter requesting users to check fuses and replace them as appropriate in accordance with their instructions.   

Oxygen Care Limited has been acting on behalf of the manufacturer Respironics (UK) Limited, following up on the corrective action relating to this device on the Irish market.   

The IMB have been advised that approximately 197 devices on the Irish market still require modification.  Oxygen Care Limited has recently written to remind all customers and to seek their assistance in locating and accessing these devices.

Profile Respiratory System CR60 and Porta-Neb DOcument

Actions To Be Taken:
  • Advise Oxygen Care Limited of the number and location of all affected devices in your institution.  
  • Ensure the modification is carried out on all affected devices.
    •

    Further Information:
    All adverse incidents relating to a medical device should be reported to the:   

    Health Products Regulatory Authority
    Medical Devices Department 
    Kevin O'Malley House 
    Earlsfort Centre 
    Earlsfort Terrace 
    Dublin 2   

    If you have any enquiries, you may contact the Medical Devices Department at:   

    Telephone:    +353-1-6764971 
    Fax:              +353-1-6344033 
    Email:            medicaldevices@imb.ie 
    Website:        www.hpra.ie  

    Enquiries to the manufacturer should be addressed to:   

    Mr. Karl Goulding 
    Oxygen Care Limited 
    Corrig Road 
    Sandyford Industrial Estate 
    Dublin 18   

    Telephone:    +353-1-2953421 
    Fax:              +353-1-2953366 
    Email:            k.goulding@oxygen-care.ie

    SN2006(02): Profile Respiratory System CR60 and Porta-Neb

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