Events

Avis De Sécurité sur LIFEPAK 1000

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 Physio-Control.

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
    Physio-control received 34 incident reports where customers attempted to use their lifepak 1000 defibrillator and the device unexpectedly switched off during the treatment of the patient. this unexpected shutdown is due to interruptions in the connection between the battery and the device contacts. in this scenario, the defibrillator may not be therapeutic during resuscitation attempts, which can put the patient at risk of serious injury or death. we know examples of 8 negative events in connection with this problem.

Device

LIFEPAK 1000

Manufacturer

Physio-Control
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    AMPMDRS