Events

Field Safety Notices about Carestation 600

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
    2016-02-10
  • 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 bvt switch may be difficult to move between the operating modes of the mechanical ventilation and the hand bag or it remains in the position and the patient can not be overcome by an anesthetic system. this problem can lead to loss of patient overflow and leads to hypoxia. so far, there have been no reports of injuries or complaints resulting from this problem. if the above problem occurs and no mechanical or manual ventilation mode can be used, a backup method is required for the patient's breathing. if problems with patient overflow occur, use a self-inflating bag immediately. before using the instructions, both in the user manual of the device and in the system's unsupervised system, include instructions on how to check whether the spare spraying, regardless of an anesthetic device, is available and working.

Device

Carestation 600
  • Model / Serial
    Carestation 620 A1 (GTIN: 00840682103985): SM615020004WA to SM616010008WA; Carestation 650 A1 (GTIN: 00840682103947): SM715020005WA to SM716010008WA; Carestation 650c A1 (GTIN: 00840682103954): SM815020001WA to SM815500001WA.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare