Events

Avis De Sécurité sur Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED

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

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(18)
  • Date
    2012-12-17
  • 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=/defibtech-ddu-100-series-aed-marketed-under-the-brand-names-lifeline-aed-reviver-aed-and-lifeforce-aed&id=b97cf825-9782-6eee-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
    Certain defibtech ddu-100 series aeds marketed under the brand names lifeline aed, reviver aed and lifeforce aed may not deliver therapy.
  • Action
    1. Ensure that the relevant personnel in your organisation are made aware of the attached FSN and its content.  2. Determine if you have purchased a device that is affected by this issue by reviewing the attached FSN.  3. If you have an affected device, please follow the instructions provided by Defibtech LLC in the attached FSN.

Device

Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifefor...
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED
  • Manufacturer
    Defibtech LLC

Manufacturer

Defibtech LLC