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Graseby MR10 Neonatal Respiration Monitor

Notice type: Advisory

Date: 20/06/2012

  

Product name or type:
Graseby MR10 Neonatal Respiration Monitor

Reference:
SN2012(06)

Manufacturer Or Supplier:
Smiths Medical International

Target Audience:
General Public 
Hospital CEOs 
Hospital Staff 
Paediatric Staff 
Medical Centre CEOs 
Medical Centre Staff 
Paramedics 
Ambulance Staff 
Clinical Risk Managers 
Clinical Nurse Managers 
General Practitioners / General Practice Nurses / Assistants 
Theatre Managers 
Accident & Emergency Staff 
Community Care Centres 
Public Health Nurses Community Healthcare Workers 
EBME and Clinical Engineering Departments 
Medical Device Distributors 
Neonatal Charity Organisations 

Problem Or Issue:
Graseby MR10 Neonatal Respiration Monitor devices may stop functioning without producing an alarm.

Background Information Or Related Documents:
In December 2011, Smiths Medical issued a Field Safety Notice (FSN) to affected customers highlighting an issue with a number of Graseby MR10 Neonatal Respiration Monitors. Smiths Medical “identified that the three battery straps (also known as “battery contacts”, in the MR10 battery box can become permanently deformed, causing the batteries to make only intermittent contact. If this condition occurs during use, then the MR10 may stop functioning without producing an audible alarm. If this condition occurs during an apnoea event, and if it is not observed that the indicator light is no longer lit, this could result in serious injury or death.” 

Smiths Medical gave customers the option to return affected monitors to their facility for the correction to take place, or customers had the option to perform the upgrade themselves upon receipt of a service kit from Smiths Medical. For all customers who have not returned their devices for upgrade or who have not performed the upgrade themselves, the Irish Medicines Board (IMB) emphasise the importance of completing this corrective action and urge users of the affected devices to complete the replacement of the affected battery straps immediately. 

The FSN is attached for your information. It is important that this IMB Safety Notice and the attached FSN is passed on to all personnel who need to be aware within your organisation and it must also be ensured that this IMB Safety Notice and the attached FSN is passed on to any organisation or end user where the potentially affected devices have been transferred. 

All relevant details regarding this Field Safety Corrective Action are outlined in the attached FSN, including details of the correction for the above device to remove and replace affected battery straps. 

If users have any concerns regarding this device please contact the manufacturer for further guidance. 

Graseby MR10 Neonatal Respiration Monitor Document

Actions To Be Taken:
The IMB recommends that: 

1. Relevant personnel in your organisation are made aware of this potential issue. 
2. If applicable, users complete the outstanding corrective action (i.e. replacement of affected battery straps) without delay. 
3. Ensure that this IMB Safety Notice and the attached FSN is passed on to any organisation or end user where the potentially affected devices have been transferred. 

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

Manufacturer 

Smiths Medical International Ltd. 
1265 Grey Fox Road 
St. Paul, MN 
55112 
USA 

Telephone: +1 651-628-7164 
Fax: +1 800-237-8033 
Contact person: Mr. Mick Boydon 
Email: MR10BatteryStraps@smiths-medical.com 


Competent Authority 

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

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie

Please click here to download a PDF version of the Safety Notice

Please click here to download the FSN

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