Millennium Oxygen Concentrator

Notice type: Advisory

Date: 13/06/2011


Product name or type:
Millennium Oxygen Concentrator

IMB Safety Notice: SN2011(12)

Manufacturer Or Supplier:
Philips Respironics

Target Audience:
Hospital CEOs 
Community Care Managers 
Community Therapists 
Health Visitors 
Risk Managers 
Loan Store Managers 
Childrens Disability Services 
Educational Establishments 

Problem Or Issue:
Philips Respironics is aware that a small number of Millennium Oxygen Concentrators on the Irish market may not yet have received a capacitor upgrade. The potentially affected population was manufactured between July 2003 and August 2004.

Background Information Or Related Documents:
The Irish Medicines Board (IMB) is aware of two incidents involving Millennium Oxygen Concentrators where thermal damage occurred as a result of a failure of a plastic capacitor component. In November 2005, Philips Respironics initiated a corrective action to replace the plastic start/run capacitor with a metal start/run capacitor at the next routine service. There is a possibility that approximately 73 Millennium Oxygen Concentrators, which have not received the replacement metal capacitor, may remain on the Irish market. The potentially affected population of products were manufactured between July 2003 and August 2004. 

Millennium Oxygen Concentrators were manufactured with a plastic start/run capacitor from July 2003 through August 2004. During August 2004, Philips Respironics rebranded the Millennium Oxygen Concentrator product and at that time a metal start run capacitor was placed into the concentrator. All Millennium Oxygen Concentrators manufactured since August 2004 have a metal capacitor installed. 

Philips Respironics issued a Technical Bulletin in November 2005 to their distributors/authorized service centres of the above-mentioned devices, initiating a corrective action to replace the plastic start/run capacitor with a metal start/run capacitor at the next routine service. 

Philips Respironics has advised that they supplied 916 Millennium Oxygen Concentrators to the Irish market. While the vast majority of these devices (>92%) have received the upgraded capacitor, there remain some devices which cannot be located. The IMB acknowledges the efforts made by the manufacturer and their distributors to locate these units. The IMB is issuing this safety notice to ensure all users are aware of the potential problem.

Millennium Oxygen Concentrator Document

Actions To Be Taken:
1) Ensure the appropriate personnel are made aware of this notice. 
2) Identify the location of all Philips Respironics Millennium Concentrators. 
3) Determine if you / your institution has devices affected by this issue. 
4) Ensure that corrective action is completed on all affected devices. 

Further Information:
Enquiries to the distributors should be addressed to: 

Respironics Deutschland                                 
Gewerbestrasse 17                                          
82211 Herrsching 

Tel: +49 8152 930600 
Fax: +49 8152 930618 

Air Products Ireland Ltd                            
18H Rosemount Business Park                   
Dublin 11                                                 
Republic of Ireland  

Tel: +353 (0) 1 809 1800 
LoCall: 1850 24 02 02
Fax: +353 (0) 1 829 3966 
Freephone from NI: 0800 3285875 

BOC Healthcare                                         
Blyry Industrial Estate                                 
Co. Westmeath                                          
Tel: +353(0) 9064 70910 
LoCall: 1890 220202 
Fax: +353(0) 9064 74993 

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

Health Products Regulatory Authority 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 

Please click here to download a PDF version of the safety notice

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