The Medicines and Healthcare products Regulatory Agencies (MHRA), United Kingdom has issued a Field Safety Notice advising users of a voluntary correction of a limited number of Graseby MR10 Neonatal Respiration Monitors.
Medical device manufacturer, Smiths Medical, has identified that the three battery straps 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.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.