Events

Avis De Sécurité sur CARAT I pro and CARAT II pro Ventilators

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 HOFFRICHTER 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
  • 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
    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