Events

Avis De Sécurité sur EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par EMS Medical.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2012(13)
  • Date
    2012-08-24
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    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 / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    HPRA