Events

Field Safety Notices about Fred Easyport

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 SCHILLER.

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
    2016-03-08
  • 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
    We have received an incident report of fred easyport where the ecg trace showed a ventricular fibrillation. fred easyport decided for a shock delivery correctly. during the loading of capacitor fred easyport analyzed further and due to the short change of rhythm fred easyport diverted the shock internally and asked the user to resume cpr (cardiopulmonary resuscitation) immediately. the fred easyport in question had as special feature automatic analysis every 2 minutes; however, the standard fred easyport analyses upon pressing "analysis" button, i.E. 1st and 2"ct categories (for detail, see below). the user is prompted to do so every 2 minutes. .

Device

Fred Easyport

Manufacturer

SCHILLER