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 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 138 09 12 000
  • Event Initiated Date
    2012-09-16
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2393
  • 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
    Increasing numbers of cases in which significant quantities of compressed air escaped during generation of compressed air in the hospital. this was due to a failure of input valves in the ecopharm tower absorption dryer. in one case, both redundant dryers failed within 24 hours, resulting in a compressed air shortage warning on the hospital's wards. there has been no report of any failure of medical devices, nor of any personal injury.

Device

medical air, Compressed Air System and dryer
  • Model / Serial
    EcoPharm Tower MA DME 0125-805
  • Product Description
    Compressed Air System
  • Manufacturer
    Draeger Medical Inc

Manufacturer

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