Events

Field Safety Notices about CARAT I pro and CARAT II pro Ventilators

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by HOFFRICHTER GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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