Events

Field Safety Notices about Graseby MR10 Neonatal Respiration Monitor

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Smiths Medical International.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2012(06)
  • Date
    2012-06-20
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/graseby-mr10-neonatal-respiration-monitor&id=277ff825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Graseby mr10 neonatal respiration monitor devices may stop functioning without producing an alarm.
  • Action
    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.

Device

Graseby MR10 Neonatal Respiration Monitor

Manufacturer

Smiths Medical International