Events

Field Safety Notices about EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder

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

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(13)
  • Date
    2012-08-24
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/ems-medical-neonatal-paediatric-endotracheal-tube-clamp-holder&id=d27df825-9782-6eee-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
    The composition of the plastic used to make the clamp/holder was changed to a dehp-free material. this affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction. ems medical went into administration over one year ago before this issue was identified.  the imb included a copy of mda/2012/049 in the july monthly mailing. at that time it was not known if there were any affected devices on the irish market. the imb now believe that some devices were supplied to irish customers.
  • Action
    The IMB advises healthcare professionals/users to:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify, do not use and dispose of affected devices.  3. Inform the IMB if you have affected devices at your institution.

Device

EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder
  • Model / Serial
  • Product Description
    EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    HPRA