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HARMONY LA, LC 500 and LA 700 SURGICAL LIGHTING and MEDIA SYSTEM

Notice type: Advisory

Date: 15/07/2011

  

Product name or type:
HARMONY LA, LC 500 and LA 700 SURGICAL LIGHTING and MEDIA SYSTEM

Reference:
IMB Safety Notice: SN2011(17)

Manufacturer Or Supplier:
Manufacturer: STERIS Corporation Ltd.

Distributed in Ireland by: 
ALLPHAR SERVICES 
4045 Kingswood Road 
Citywest Business Campus 
Co. Dublin 

Contact Person: Laura Jacob 
Phone: + 353 1 468 8472 

Target Audience:
Hospital Managers / CEOs 
Risk Managers 
Clinical Directors 
Clinical Engineers 
Surgeons 
Obstetricians and Gynaecologists 
Endoscopy units 
Theatre and Nursing Staff 
Purchasing Managers 
Nursing Managers 
Hospital personnel 
Medical device distributors

Problem Or Issue:
Premature bulb failures due to loosening of wires and overheating of the lamp housing assemblies within the Harmony LA, LC 500 and LA 700 Surgical Lighting and Media Systems.

Background Information Or Related Documents:
STERIS Corporation has learned that some customers may experience premature bulb failures due to loosening of wires and overheating of the lamp housing assemblies within the Harmony LA, LC 500 and LA 700 Surgical Lighting and Media Systems. 

The affected devices are those bearing serial numbers 428102135 to 0430207104 produced from August 2002 to October 2007. The Irish Medicines Board  (IMB) is aware that several affected devices have been placed on the Irish market and some of the users have not been identified by the distributor. The IMB is issuing this safety notice to ensure all users are aware of the potential problem. 

STERIS Corporation issued a field safety notice (see attached) in February 2010 recommending that customers ensure that they are adhering to the Harmony LA, LC 500 and LA 700 Surgical Lighting and Media System Operator Manuals by: 
- Not touching the glass portion of the lamp with bare fingers as this can cause deterioration of material, leading to possible failure of the bulbs; 
- Using only STERIS replacement bulbs in the lighting system; use of other than those provided by STERIS may damage equipment; 
- Placing the lighting system into STANDBY or OFF mode when not in use.

HARMONY LA, LC 500 and LA 700 SURGICAL LIGHTING and MEDIA SYSTEM Document

Actions To Be Taken:
The IMB advise that you: 

• Check if you have these devices in your institution. 
• If you have any of these identified devices in your institution, contact ALLPHAR SERVICES to arrange an upgrade of the lamp housing assembly. 
• Ensure that you adhere to the manufacturer’s Operator Manual for use and maintenance of the product. 

Further Information:
Enquiries to the Irish distributor should be addressed to: 

ALLPHAR SERVICES 
4045 Kingswood Road 
Citywest Business Campus 
Co. Dublin 

Contact Person: Laura Jacob 
Phone: + 353 1 468 8472 

Enquiries to the manufacturer should be addressed to: 

STERIS Corporation Ltd. 
Chancery House, 
190 Waterside Road, 
Hamilton Industrial Park, 
Leicester, 
LE5 1QZ, UK 

Contact person: Louisa Ballard 
Telephone: +44 (0) 116 276 8636 
Fax: +44 (0) 116 276 8639 
E-mail:   Louisa_Ballard@steris.com

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 
E-mail: vigilance@imb.ie 
Website: www.hpra.ie 

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

Please click here to download a pdf version of the Field Safety Notice

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