Notice Information: - Advisory - 20/06/2012
Title:
Graseby MR10 Neonatal Respiration Monitor
Product:
Graseby MR10 Neonatal Respiration Monitor
Reference:
SN2012(06)
Manufacturer / 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
Issue:
Graseby MR10 Neonatal Respiration Monitor devices may stop functioning without producing an alarm.
Background Information / 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.
Action 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
Irish Medicines Board
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.imb.ie
Please click here to download a PDF version of the Safety Notice
Please click here to download the FSN