Events

Avis De Sécurité sur Defibrillation electrodes for Lifepak

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Cardinal Health.

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
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    The drawing on the defibrillation electrodes manufactured by cardinal health does not meet the specifications of physio-control and shows incorrect placement of the electrodes on the baby. there are no problems with the function or function of the defibrillation electrodes, but only an incorrect drawing on the defibrillation electrodes in the package. the drawing on the electrode package shows the correct placement of the electrodes on the baby. if the user improperly installs defibrillation electrodes, it can lead to inefficient energy delivery to the patient. this can lead to failed defibrillation and serious injury or death.

Device

Defibrillation electrodes for Lifepak

Manufacturer

Cardinal Health