Events

Notificaciones De Seguridad De Campo acerca de PRIMEDIC™ AkuPak LITE

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Metrax GmbH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-06-07
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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