Events

Field Safety Notices about SERVO-i/s ventilator systems software 8.00.00

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 Maquet Critical Care AB.

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
    The improper behavior in system sw version 8.00.00 appears as follows:  if ventilation is started with infant factory default settings, the following settings will apply: o pressure control mode o 10 cmh2o pc above peep.  the system will however deliver a pressure of 20 cmh2o above peep as long as the factory default setting 10 cmh2o is used unchanged. the error was discovered at the production site and there are no reported injuries. .

Device

SERVO-i/s ventilator systems software 8.00.00

Manufacturer

Maquet Critical Care AB
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS