Events

Avis De Sécurité sur LIFEPAK CR® Plus AED and LIFEPAK EXPRESS®

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 has encountered a problem where aifs lifepak cr plus or lifepak express do not start sounding when the on / off button is pressed when the cover is opened due to an internal component (pole switches), however, it may occasionally remain fixed in the closed position. physio-control has found that there are currently 25,178 devices in circulation, of which about 9,600 have this defective component. such a defibrillator will not trigger shock, so potential treatment will not be performed and the patient will not be resuscitated. all reports we received from customers were provided at initial preparation and when testing the device. to date, we have not received reports of patient-related events.

Device

LIFEPAK CR® Plus AED and LIFEPAK EXPRESS®

Manufacturer

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