Events

Avis De Sécurité sur PRIMEDIC™ AkuPak LITE

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 Metrax GmbH.

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
    2016-06-07
  • 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
    If the primedic™ defimonitor xd is stored for long periods with the primedic™ akupak lite inserted and with direct connection to the mains power via the integrated mains unit, the defibrillator is only supplied from this source in the course of the daily self-test, i.E. no power is taken from the battery inserted in the unit. this means that the battery management system (bms) integrated in the primedic™ akupak lite will not have its residual capacity checked by a new evaluation throughout the entire period. for this reason, internal power consumption and chemical self-discharge of the cells can result in a reduction in the capacity, without starting a charging process for the primedic™ akupak lite. a new evaluation of the residual capacity will only take place when the primedic™ defimonitor xd is disconnected from the mains and is switched on. .

Device

PRIMEDIC™ AkuPak LITE

Manufacturer

Metrax GmbH