Events

Field Safety Notices about Carestation 620, 650 in 650c

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 GE Healthcare.

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
  • Date
    2017-05-16
  • 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
    Problem 1: between the removable receptacle and the lower circuit of the respiratory circuit on the carestation 600 systems, there is possibility of incomplete sealing. this incomplete seal may lead to a re-inhaling of the patient's gases that overturn the carbon dioxide (co2) absorbing agent, which can lead to an unscheduled rise in the level of inhaled co2 (fico2), which can consequently lead to hypercapnia. problem 2: carestation 600 systems can experience an unexpected transition to a failure state. in this case, the following message appears on the screen: "internal system failure prevents normal operation. use a spare respiratory system. turn off and turn on the station to restart. ".

Device

Carestation 620, 650 in 650c
  • Model / Serial
    Carestation 620 A1 (GTIN: 00840682103985); Carestation 650 A1 (GTIN: 00840682103947); Carestation 650c A1 (GTIN: 00840682103954)
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare