Events

Avis De Sécurité sur Fred Easyport

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 SCHILLER.

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
  • Date
    2016-03-08
  • 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
    We have received an incident report of fred easyport where the ecg trace showed a ventricular fibrillation. fred easyport decided for a shock delivery correctly. during the loading of capacitor fred easyport analyzed further and due to the short change of rhythm fred easyport diverted the shock internally and asked the user to resume cpr (cardiopulmonary resuscitation) immediately. the fred easyport in question had as special feature automatic analysis every 2 minutes; however, the standard fred easyport analyses upon pressing "analysis" button, i.E. 1st and 2"ct categories (for detail, see below). the user is prompted to do so every 2 minutes. .

Device

Fred Easyport
  • Modèle / numéro de série
  • Manufacturer
    SCHILLER

Manufacturer

SCHILLER