Events

Avis De Sécurité sur Nellcor Durasensor® (DS-100A) sensors Product Code: DS-100A

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

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
    SN2011(01)
  • Date
    2011-01-21
  • 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=/counterfeit-covidien-nellcor-spo2-durasensor-(ds-100a)-sensors&id=1589f825-9782-6eee-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 supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Action
    The IMB advises that:  • All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.  • If from your assessment you determine or suspect that you have product that is counterfeit identify, locate and quarantine all product to ensure it will not be used.  • If you identify that you have product that is counterfeit you should submit the information detailed in Appendix I to theHPRA (enforcement@hpra.ie). On receipt of this information the IMB will contact you to advise what further course of action is required.

Device

Nellcor Durasensor® (DS-100A) sensors Product Code: DS-100A
  • Modèle / numéro de série
  • Description du dispositif
    Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors
  • Manufacturer
    Tyco Healthcare group LP

Manufacturer

Tyco Healthcare group LP
  • Source
    HPRA