Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Draeger Medical Systems Inc..

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 087 02 17 000
  • Event Initiated Date
    2017-02-23
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10705
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Safety feature checking the display function may detect a failure leading to a controlled reboot of the cockpit infinity c500 of evita infinity v500 or babylog vn500. as the cockpit infinity c500 operates independently from the ventilation unit evita infinity v500 or babylog vn500, ventilation will continue as set. should the reboot of the cockpit c500 fail, a message “boot disk error” will remain on the screen.

Device

IACS monitoring, PulmoVista 500, Work Station Critical Care and Work Station Neonatal Care
  • Model / Serial
    Cockpit Infinity C500 (MS18746) used for the devices Dräger Infinity ACS Critical Care Workstation (Evita Infinity V500) and Dräger Infinity ACS Neonatal Care Workstation (Babylog VN500).
  • Product Description
    Critical Care Workstation
  • Manufacturer
    Draeger Medical Systems Inc.

Manufacturer

Draeger Medical Systems Inc.
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Manufacturers representative
    Draeger Arabia Co. Ltd.
  • Source
    SFDA