Events

Field Safety Notices about Drager Infinity AC8 Workstation Critical Care (Evita Infinity V500), Drager Infinity AC8 Workstation Neonatal Care (Babylog VN500) and Drager Evita V300

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 Drager.

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
    Within the framework of our post market surveillance activities, we became aware about an event in which the battery capacity of the optional p8500 of an iacs workstation critical care (evita infinity v500) did not last as long as expected. the batteries installed in the p8500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. the sequential alarms ,,battery low“ followed by “battery depleted" were given, however, the remaining time until the ventilator shut down was not foreseeable. when the battery depleted totally, the power fail alarm was generated.

Device

Drager Infinity AC8 Workstation Critical Care (Evita Infinity V500), Drager Infinity AC8 Workstat...

Manufacturer

Drager