Events

Notificaciones De Seguridad De Campo acerca de CARAT I pro and CARAT II pro Ventilators

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 HOFFRICHTER 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
  • 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
    During the boot-up of caratpro ventilators the software carries out an integrity check of the last used settings and ventilation parameters. in case the alarm for “high frequency” was set to “off” the setting is falsely recognized as corrupt. thereafter during the device restart the software’s security routine restores the factory defaults instead of the previously used parameters for safety reasons. this takes place without informing the user by technical notification or alarm. both, the false recognition of the “high frequency” alarm setting and the absent information of the user, are part of a software bug. this bug is present in all software versions up to and including version 2.003 and is corrected with software version 2.004 and above. all devices with installed software version 2.004 are not affected by this .

Device

CARAT I pro and CARAT II pro Ventilators

Manufacturer

HOFFRICHTER GmbH